Informed Consent

DR. RAJEENTHERAN SUNTHERALINGAM
MBBS, FRCS (Edin), FRCS (Glasgow), FRCS UROLOGY (Glasgow),
MBU Urology (Mal), AM (Mal)
Advanced Urological training (Bristol Urological Institute, U.K),
Certificate in Urodynamics (Bristol), Urology Board Certificate (Mal)

NOTE: This website is in English. However, for those who wish to, can use Google translate in Google Chrome to translate to any language of their liking – Malay, Chinese, Tamil, Hindi, etc. The translation is reasonably good, but accuracy cannot be verified, and one should not be fully reliant on these translation although they may be reasonably helpful.

Informed Consent

Consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. Consent is a process of communication between you and your health care provider that often leads to agreement or permission for care, treatment, or services. Every patient has the right to get information and ask questions before any procedures and treatments.

A valid consent on the other hand is the voluntary agreement by an individual to a proposed procedure, given after appropriate and reliable information has been given about the procedure, including the potential risks and benefits has been conveyed to the individual.

Valid Consent

It is generally accepted that consent to be “valid” should be “informed”; the requirements for obtaining valid consent are that it must:

  1. be given to a person with legal capacity, and of sufficient  intellectual capacity to understand the implications of undergoing the proposed procedure,
  2. it must be taken in a language which the person understands,
  3. it must be given freely and voluntarily, and not coerced or induced by fraud or deceit,
  4. it must cover the procedure to be undertaken, the person must have an awareness and understanding of the proposed procedure and its known or potential  risks,
  5. the person must be given alternate options to the proposed treatment or procedure,
  6. the person must have sufficient opportunity to seek further details or explanations about the proposed treatment or procedure and material risks should be explained.

Material Risk

A “material risk” is one in which “a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it”.

Required elements for an informed consent

Informed consent is both an ethical and legal obligation of medical practitioners.

The following are the required elements for documentation of the informed consent discussion:

(1) The nature of the procedure,

(2) The risks and benefits and the procedure,

(3) Reasonable alternatives,

(4) Risks and benefits of alternatives, and

(5) Assessment of the patient’s understanding of elements 1 through 4.

Information that should be disclosed may include:

  1. Discussion on serious and common risks
  2. Details of the diagnosis and prognosis, as well as the prognosis if the condition is left untreated
  3. The various options for treatment or management
  4. Purpose of the treatment
  5. What the patient might experience during the procedure including common and serious side effects
  6. Likely benefits and probabilities of success of the treatment
  7. Any lifestyle changes which may be caused by the treatment
  8. How and when the patient’s condition and side effects will be monitored
  9. A reminder that patients can change their mind at any time
  10. A reminder that patients have the right to seek a second opinion
  11. Where applicable, details of costs or charges involved

Necessity to Warn Patients about Material Risks

A “material risk” is one in which “a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it”.

Every patient as an individual has a choice whether or not to undergo a proposed procedure, surgery, examination or treatment. A medical practitioner is obliged to disclose information to the patient and to warn the patient of material risks before taking consent.

Relevant information includes disclosure of possible risks which the patient ought to know and/or should know. The medical practitioner must inform the patient, in a manner that the patient can understand, about the condition, investigation options, treatment options, benefits, all material risks, possible adverse effects or complications, the residual effects, if any, and the likely result if treatment is not undertaken, to enable the patient to make his own decision whether to undergo the proposed procedure, examination, surgery, or treatment.

Disclosure of information:

For informed consent for treatment or tests, the doctor must give (or disclose) to the patient enough information so that the patient can make an informed decision. It is not necessary or expected that the patient would receive every detail of the test, treatment, or procedure. You need only the information that would be expected by a reasonable person to make an intelligent decision. This information should include the risks and likelihood (or probability) of each of the risks and the benefits, and likelihood (or probability) of benefit. Any questions the patient has should be fully explained, in language and terminology that he or she can understand.

The above components should be discussed and included in the written consent form.

Your doctor will discuss with you regarding the procedure and obtain an informed consent as well as to allow you to make an informed decision on your treatment.

The following are the format of informed consents for various urological procedures. Kindly note that this is only a general format, and other explanations and material risks can only be ascertained by your doctor after a consultation, detailed history and discussion of your ailments.

Informed Consent for various Urological Procedures:

Prostate Biopsy (English)

TRANSRECTAL BIOPSY OF THE PROSTATE (TRUS BIOPSY)

The above procedure is done as an outpatient procedure, or a day-ward admission.

The purpose of the procedure is to evaluate your prostate for any possible focus of cancer. At times they are also done in infertility cases where biopsy may not be needed.

You will be given a course of antibiotics the day before the procedure, and you will be advised to continue this antibiotic for the next 5 days.

This procedure involves:

  1. A rectal examination to assess your prostate for any abnormalities
  2. Placing a probe into your rectum (back massage)
  3. Taking a few biopsies from your prostate

Either sedation or local anesthetic infiltration will be given before the procedure. Kindly indicate to the doctor if you are allergic to any medications prior to the procedure

The complications of the procedure include:

  1. Pain / discomfort
  2. Infection – fever
  3. Bleeding in the urine (hematuria)
  4. Bleeding in the rectum / back passage (hematochezia)
  5. Bleeding in the semen

If you do have the above complications, namely:

  1. Fever
  2. Persistent bleed more than 3 days
  3. Excessive bleed within the first 3 days
  4. The feeling of dizziness or unwell
  5. Inability to pass urine after the procedure

then please come back immediately to the clinic, or to the emergency department after office hours.

An appointment will be given to you to see me in the clinic after the above procedure, and to evaluate the biopsy results.

.

Prostate Biopsy (Malay)

PEMERIKSAAN KELENJAR PROSTATE MELALUI DUBUR

Tatacara ini dilakukan sebagai kes pesakit luar atau dimasukkan ke wad Daycare untuk sehari.

Tujuan tatacara ini ialah untuk  memeriksa kelenjar prostate yang berkemungkinan mengalami tanda-tanda barah. Kadangkala tatacara ini juga dilakukan bagi kes-kes kemandulan dimana biopsi tidak diperlukan.

Anda akan diberikan ubat antibiotik sehari sebelum tatacara tersebut dan anda dikehendaki untuk mengahabiskan ubatan tersebut untuk lima hari berikutnya.

Tatacara ini melibatkan :

  1. Pemeriksaan kelenjar prostate melalui dubur untuk mengesan tanda-tanda luar biasa
  2. Satu alat “probe”akan dimasukkan ke dalam dubur
  3. Mengambil biopsi dari kelenjar prostate

Sebelum tatacara ini, anda akan diberi bius tempatan atau bius separuh sedar.

Sila beritahu doktor jikalau anda ada apa-apa alahan dengan mana-mana ubat tertentu.

Komplikasi tatacara ini adalah :

  1. Sakit / rasa kurang selesa
  2. Jangkitan – demam
  3. Pendarahan air kencing
  4. Pendarahan melalui dubur
  5. Pendarahan melalui air mani

Jikalau anda mengalami tanda-tanda komplikasi diatas seperti berikut:

  1. Demam
  2. Pendarahan yang melebihi 3 hari
  3. Pendarahan yang berlebihan pada 3 hari yang pertama
  4. Rasa pening kepala atau kurang selesa
  5. Susah untuk membuang air kencing

Anda mesti datang segera ke klinik, atau terus  ke jabatan kecemasan selepas waktu pejabat

Tarikh temujanji akan diberi kepada anda untuk mengetahui keputusan biopsi.

Vasectomy

CONSENT FOR VASECTOMY

I, the undersigned, request a bilateral vasectomy, a procedure to produce obstruction of the vas deferens for the purpose of producing sterility.

I understand there can be no absolute guarantee that this or any procedure will be successful.

It is understood, however, that my semen will be checked following the operation.

I understand that contraception must be practiced until there are no sperm present.

I also understand that while the reversal success rate is quite good, it is not 100 %, and vasectomy should therefore be considered a permanent or irreversible procedure.

I recognize a small chance that I might have to return to the hospital for evaluation and treatments in case of any complications.

I also understand that the late complications of sperm granuloma, scrotal pain and recanalization of the vas are possible.

By consenting to vasectomy and accepting the risks outlined above, I release the urologist involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications.

 

ESWL (Extracorporeal Shock Wave Lithotripsy)

EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL)

The above procedure is done either as an outpatient or inpatient procedure.

Extracorporeal shock wave lithotripsy (ESWL) uses sound waves (also called shock waves) to break a kidney or ureteric stone into small pieces that can more easily travel through the urinary tract and pass from the body.

  • You will lie on a water – filled cushion, and the urologist uses X-rays or ultrasound tests to precisely locate the stone. High-energy sound waves pass through your body without injuring it and breaks the stone into small pieces. These small pieces move through the urinary tract and out of the body more easily than a large stone.
  • The process takes about 60-90 minutes.
  • You may receive sedatives or local anaesthesia
  • Your urologist may use a stent (small, short tube) when your stones are large or if the urinary tract is infected. This helps the small stone pieces to pass without blocking the ureter. This stent cannot be kept in longer than a few weeks, maximum 3 months.

Before the procedure kindly also inform the doctor if you have the following:

  • Kindly indicate to the doctor if you are on any anti – platelets (aspirin, disprin, cardiprin, plavix / clopidogrel and even warfarin) or any herbal or traditional medications as these can cause bleeding during and after the ESWL therapy. The anti-platelets must be stopped 7-10 days before the procedure.
  • Pre-existing, poorly controlled hypertension (high BP) may lead increases risk of bleeding
  • If you are allergic to any medications prior to the procedure
  • If you have a cardiac pacemaker (may require gated lithotripsy)

Kindly also inform your doctor if you have the following (ESWL usually is not performed)

  • Pregnancy: The sound waves and X-rays may be harmful to the baby
  • Have a bleeding disorder.
  • Have a kidney infection, urinary tract infection or kidney cancer.
  • Have kidneys with abnormal structure or function

RESULTS OF ESWL THERAPY:

The purpose of ESWL therapy is to fragment the stone to smaller pieces.

After ESWL, stone fragments usually pass out of the body within a few weeks. Sometimes small stones will persist, but as long as they are not large, they can undergo surveillance.

If you have a larger stone, you may need more ESWL therapies or even other treatments.

RISKS OF ESWL THERAPY:

Complications of ESWL therapy include:

  • Pain caused by the passage of stone fragments.
  • Blocked urine flow as a result of stone fragments becoming stuck in the urinary tract. The fragments may then need to be removed with ureteroscopy (placing a scope into the ureter).
  • Urinary tract infection.
  • Bleeding around the outside of the kidney with bruising – either to the skin or the kidney

AFTER ESWL THERAPY:

Drink plenty of water – this will make it easier and more comfortable to pass water and help to flush any stone fragments.

Some discomfort is normal, as is a little blood in the urine.

You may pass some sand or gravel in your urine. This should not be painful.

If you experience renal colic (severe pain in the side and back), pass a large amount of blood or feel unwell with fever, you should come down to the hospital emergency immediately.

WHAT TO EXPECT AFTER TREATMENT:

It may take a few days or weeks for all the stone fragments to pass from your body. You may have mild pain as the small fragments pass through the urinary tract.

CONTACT YOUR UROLOGIST IF:

  1. You have severe pain after the procedure
  2. You have fever
  3. You have excessive bleeding in the urine
  4. You feel giddy / faint

Extracorporeal shock wave lithotripsy (ESWL)

Extracorporeal shockwave lithotripsy (ESWL) uses sound waves (also called shock waves) to break a kidney stone into small pieces that can more easily travel through the urinary tract and pass from the body.

You lie on a water-filled cushion. X-rays or ultrasound tests are used to precisely locate the stone. High-energy sound waves pass through your body without injuring it and break the stone into small pieces.

If you are unsure of the above explanation, kindly inform your doctor to re-explain them.

An appointment will be given to you to see the doctor in the clinic within 1-2 weeks after the procedure.

I, the undersigned, consent for the procedure of ESWL therapy.

By consenting to ESWL therapy and accepting the risks outline above, I release the urologist involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications. I have been explained of the risks of ESWL therapy and the possibility of further ESWL therapy or an alternative procedure if the ESWL therapy was unsuccessful or complicated.

Ureteroscopy

URETEROSCOPY

The above procedure is done as an inpatient procedure (or day-care procedure in selected cases). The procedure involves inserting a cystoscope (endoscope instrument) into your bladder followed by insertion of a ureteroscope (endoscope instrument) with the help of a guide wire into your ureter up to your kidney if possible.  Before inserting this, imaging (x-rays) will be done using contrast material to outline your kidney and ureter

Before the procedure, the following may be done:

  1. Blood investigations will be taken
  2. Explanation of the procedure as below

Kindly indicate to the doctor if you are allergic to any medications prior to the procedure.

Kindly indicate to the doctor if you are pregnant.

Kindly indicate to the doctor if you are on any anti-platelets (asprins, disprin, cardiprin, plavix /Clopidogrel and even warfarin) or any herbal or traditional medications as these may cause bleeding during and after the operation.

The procedure involves:

  1. Spinal / epidural or general anaesthesia and this will be decided by your anaesthetist.
  2. Placing a cystoscope through your urethra and proceed with imaging, followed by insertion of a ureteroscope into your ureter up to your kidney.
  3. There are times when there may be difficulty in inserting the ureteroscope as a result of a tight ureter. The urologist will then decide if this requires balloon dilatation or to terminate the procedure with insertion of a stent and henceforth proceed with the same procedure again at a later date.
  4. There are times when infected urine is noticeable during the procedure. The urologist will decide if it is necessary to terminate the procedure.
  5. Small stones may propulse back into the kidney during procedure due to the pressure of the irrigation, and this stone will not be possible to be retrieved. This may then require ESWL therapy later.
  6. A ureteric stent (tube) is usually inserted into your ureter which will then be removed at a later date. Kindly note that this stent cannot be kept permanently and must be removed within 3 months after its insertion. The date for the stent removal will be given to you by your doctor.
  7. You may be on a urethral catheter after the procedure.

The complications of the procedure include:

  1. Bleeding – usually mild blood – stained urine, at times can be more obvious bleeding
  2. Sepsis / infection – you may have fever after the operations. To prevent this, prophylactic antibiotics will be administered during the operation. At times there may be high fever with chills and rigor and this may require intensive therapy and monitoring.
  3. Perforation of the ureter by the guide wire – this usually heals by itself after placing a stent.
  4. Rarely (1 in 400 -500 cases) – avulsion (complete tearing out) of the ureter – this occurs when the ureter is too tightly snug on the scope and is pulled out when the procedure is being completed. This may require major surgery or even removal of the kidney.
  5. Anaesthetic complications – uncommon in these days in a fit and healthy patient – this will be discussed with you by your anaesthetist

An appointment will be given to you to see the doctor in the clinic after the above operation. A date for removal of the stent will also be given.

I, the undersigned, consent for the procedure of ureteroscopy.

By consenting to ureteroscopy and accepting the risks outlined above, I release the urologist involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications.

 

PCNL (Percutaneous Nephrolithotomy)

PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

The above procedure is done as an inpatient procedure.

Before the procedure, the following may be done.

  1. Blood investigation will be taken. Blood grouping and cross matching will be done in view of possible blood transfusion if required.
  2. Explanation of the procedure as below

Kindly indicate to the doctor if you are allergic to any medications prior to the procedure.

Kindly indicate to the doctor if you are pregnant or have any cervical (neck) osteoarthritis or osteoporosis.

Kindly indicate to the doctor if you are on any anti-platelets (asprin, disprin, cardiprin, Plavix/clopidogrel and even warfarin) or any herbal or traditional medication as these may cause bleeding during and after the operation. These medication should be stopped at least 7 days before the operation.

The procedure involves:

  1. General anaesthesia and this will be explained to you by your anaesthetist.
  2. Inserting a cystoscope (endoscope instrument) into your bladder followed by imaging (x-rays-) using contrast material to outline to your kidney and ureter. You will then be turned to the prone position and under imaging, your kidney will be punctured, dilated and a nephroscope will be inserted into your kidney to assess the pelvicalyceal system to remove stones or any further procedures.
  3. There are times when there may be difficulty in puncturing the kidney. The urologist will then then decide to terminate the procedure with insertion of a stent, and henceforth proceed with the same procedure again at a later date.
  4. There are times when infected urine is noticeable during the procedure. The urologist will then decide if it is necessary to terminate the procedure.
  5. A ureteric stent (tube) is usually inserted into your ureter which will then be removed at a later date.Kindly note that this stent cannot be kept permanently and must be removed within 3 months after its insertion. The date for the stent removal will be given to you by your doctor.
  1. You may be on a nephrostomy (tube through the kidney / external tube) after the operation and this may show blood / blood-stained urine.
  2. You may be on a urethral catheter after the procedure.

 The complications of the procedure include:

  1. Bleeding: requiring blood transfusion approximately 5%, requiring embolization approximately 1%, and requiring emergency nephrectomy (removal of the kidney) approximately 0.5%.
  2. Sepsis / infection – you may have fever after the operation. To prevent this, prophylactic antibiotics will be administered during the operation. At times there may be high fever with chills and rigor in spite of this antibiotics and this may require intensive therapy and monitoring and possibly ICU admission.
  3. Perforation of the ureter by the guide wire – this usually heals by itself after placing a stent.
  4. Pneumothorax and pleural effusion (air and water in between the 2 layers of the lung) approximately 10-15%: this may require a chest tube if it is clinically significant.
  5. Colonic, liver and splenic injuries are rare.
  6. Cervical (neck) injuries may occur during turning to prone position if you have severe cervical osteoarthritis / osteoporosis.
  7. Anaesthetic complications – uncommon in these days in a fit and healthy patient – this will be discussed with you by your anaesthetist.

An appointment will be given to you to see the doctor in the clinic after the above operation. A date for removal of the stent will also be given. 

I, the undersigned, consent for the procedure of PCNL or its related procedure.

By consenting to PCNL or its related procedure and accepting the risks outlined above, I release the urologist from liability for time lost from work, salary unearned, and medical expenses incurred to treat complication.

TURP (Transurethral Resection of the Prostate)

TRANSURETHRAL RESECTION OF THE PROSTATE (TURP)

The above operation is done as an inpatient procedure. The procedure involves removing your prostate using an endoscope by cutting the prostate and thus providing a channel to enable you to pass urine, and in so doing remove the obstruction from your prostate.  

Before the procedure, the following may be done:

  1. Blood investigations will be taken as well as group and cross matching of your blood for possible blood transfusion.
  2. Explanation of the procedure as below

Kindly indicate to the doctor if you are allergic to any medications prior to the procedure.

Kindly indicate to the doctor if you are on any anti-platelets (aspirin, disprin, cardiprin, Plavix / clopidogrel and even warfarin) or any herbal or traditional medications as these can cause excessive bleeding during and after the operation.

Kindly indicate to the doctor if you are on pace maker as electrocautery is used during the resection.

The procedure involves:

  1. Spinal or general anaesthesia and this will be decided by your anaesthetist.
  2. Placing a resectoscope through your urethra and proceed with resection of your prostate.
  3. You will be on a catheter after your operation to facilitate continuous irrigation of your bladder to remove blood clots and prevent clot formation.

The complications of the procedure include:

  1. Bleeding – requiring blood transfusion in approximately 5% of cases
  2. Sepsis / infection – you may have fever after the operation. To prevent this, prophylactic antibiotics will be administered during the operation
  3. TUR syndrome – there may be excessive absorption of irrigant fluid into the body during the procedure and this may manifest as fluid overload ( excessive water overload), drowsiness, confusion, vomiting, etc. if this occurs, you might possibly need monitoring with admission to the ICU
  4. Retrograde ejaculation (ejaculation may not be seen after orgasm, but semen may be ejected backwards into the bladder and seen mixed in the urine) – 90-100%
  5. Erectile dysfunction / impotence – 5%
  6. Incontinence with urgency – rushing to the toilet very often, leaking of urine before reaching the toilet – as a result of previous obstruction of the prostate and a very active bladder being released of that obstruction after the operation – 30-40%
  7. Total incontinence – continuous leaking of urine – occurring as a result of injury of the urethral sphincter approximately 1%. This may require life-long urethral catheter or an artificial sphincter operation 1 year after the TURP
  8. Anaesthetic complications – uncommon in these days in a fit and healthy patient – this will be discussed with you by your anaesthetist

You will be on a catheter with continuous irrigation after the operation.

If you are unsure of the above explanation, kindly inform your doctor to re-explain them.

An appointment will be given to you to see the doctor in the clinic within 1-2 weeks after the above operation.

I, the undersigned, consent for the procedure of TURP.

By consenting to TURP and accepting the risks outlined above, I release the urologist involved from liability for the time lost from work, salary unearned, and medical expenses incurred to treat complications.

I have also been counselled on retrograde ejaculation and incontinence.

Laparoscopic Radical Prostatectomy

LAPAROSCOPIC RADICAL PROSTATECTOMY, RADICAL PELVIC LYMPH NODE DISSECTION

INFORMATION LEAFLET AND CONSENT

This is a consent and information leaflet.

This is a major operation. This operation is done using 5-6 keyholes (laparoscopy).

The operation is done as an in-patient hospitalization and the in-patient stay will last 5-7 days or even exceeding this if necessary.

You may require post-operative ICU stay for monitoring if necessary, and mandatory ICU stay if any risks or complications were to occur.

Before the operation the following may be done:

  1. Blood and urine investigations may be taken.
  2. Blood grouping and cross matching will be done in view of possible blood transfusion if necessary
  3. Chest x-ray and ECG may be required
  4. Consent, explanation of material risks, and explanation of the procedure as below

Kindly indicate to your doctor if you are allergic to any medications prior to the procedure

Kindly indicate to your doctor if you have any underlying medical problems or any previous operations / admissions

Kindly indicate if you are on any anti-platelets or anticoagulants (aspirin, disprin, cardiprin, Plavix / clopidogrel, heparin analogues and low molecular weight heparins, prasugrel / effient, enoxaparin / lovenox, tinzaparin / innohep, fondaparinux / arixtra, rivaroxaban / xarelto, dabigatran / pradaxa, warfarin, etc) or any herbal or traditional medications as these may cause bleeding during and after operation. The doctor will decide with you on an informed decision-making on whether, and how long, that such medications should be stopped taking into account the risk-to-benefit of the outcomes of the procedure.

This procedure involves:

  1. General anesthesia, and possibly combined with epidural anesthesia for post-operative analgesia
  2. The procedure consists of radical prostatectomy (removal of your whole prostate), pelvic lymph node dissection and stitching the bladder back to the urethra
  3. There are times there may be difficulty in dissection of your prostate resulting in bleeding that may require blood transfusion
  4. You may be monitored in the HDU / ICU after the operation if necessary

What happens during the procedure?

A full general anesthetic will be used and you will be asleep throughout the procedure. In some patients, the anesthetist may also use an epidural anesthetic to minimize post-operative pain. This operation is done using 5-6 keyholes (laparoscopy). During the operation, the prostate is removed. The urethra (water pipe) is then sewn to bladder. As part of the operation, it is usual to remove the pelvic lymph nodes.

Pre-operative medical optimization:

Medical optimization (i.e. hypertension, anemia, any cardiac issues and diabetes), physical exercise and cessation of smoking and drugs or alcohol abuse are all considered as preoperative conditioning measures, and is necessary before the operation

Pre-operation:

Needs IV branula and IV fluids

Bowel preparation

TED stockings

Heparin analogues / anti-coagulations (to thin the blood to prevent blood clots) will be given after operation when the risk of bleeding is less than the benefit of DVT and pulmonary embolism prevention

IV antibiotics during operation, sometimes needs to start before operation

Advised to get chewing gum for post-operative period; chewing gum has also been shown to reduce time to flatus, time to bowel movement and reduced hospital length of stay in patients undergoing bowel surgery

Prior to surgery, carbohydrate loading is recommended in non-diabetic patients to minimize the development of insulin resistance and catabolism of protein and fat stores secondary to the physiological stress response seen in patients undergoing surgery.

Risks and complications of the operation:

Anesthesia complications – this will be discussed with you by your anesthetist.

Bleeding: Losses 300 ml to 1000 ml of blood or even more may occur during radical prostatectomy, consequently leading to blood transfusions if necessary.

Infection / Sepsis / Septicemic shock – you may have fever after the operation. To prevent this, antibiotics will be given during the operation, and at times before the operation. Antibiotics may reduce this infection risk, but cannot completely eliminate this risk.

At times, there may be high fever and chills with rigor, and even low blood pressure in spite of antibiotics. This may require intensive therapy and monitoring including ICU admission.

Rectal perforation may occur during the operation as a result of adherence of the tumor to the rectum as well as difficult dissection; with necessity for a colostomy construction (an extra stoma opening on the abdomen for faeces)

Cardiovascular and cerebrovascular events (heart attacks and strokes)

Injury to surrounding organs

Risks and complications that can occur immediately after the operation include:

Infection, sepsis, septicemic shock

Complications due to injury to surrounding organs

Cardiovascular and cerebrovascular events (heart attacks and strokes)

Post-operative DVT (deep vein thrombosis), pulmonary embolism (can be fatal)

Pneumonia, atelectasis

Complications from pelvic lymph node dissection:

Pelvic lymphocele (lymph fluid collection)

Infected collection in pelvis, abscess collection

Delayed complications (can occur few days to even few weeks after the operation):

Post-operative DVT (deep vein thrombosis), pulmonary embolism

Pneumonia, atelectasis

Sexual dysfunction:  Erectile dysfunction (inability to get an erection) – can be enhanced with medications and penile injection therapy.

Possible prolonged ICU stay

Prolonged stay resulting in financial constraints

Financial aspects:

This is a major operation. As of year 2019, the operation with post-operative stay may amount to Rm 40,000 to Rm 50,000 and may even exceed more than Rm 60,000 to Rm 80,000 or even more depending on number of days of stay and ICU stay.

After operation:

After operation you are not to eat or drink anything until instructed

You may be monitored and managed in the HDU / ICU post-operatively

You will have a nasogastric tube (tube from your nostrils into the stomach) which will be subsequently removed

You will be on an I.V. drip and probably on central venous line which may go through the neck veins

You must wear your TED stockings at all times for at least 4-5 weeks, or sometimes longer, unless instructed otherwise

Heparin analogues / anti-coagulants will be started after the operation for which the time this will be instituted would depend on the risk to benefit of bleeding post-operatively versus that of preventing DVT and pulmonary embolism

You will be encouraged to mobilize as soon as possible after the operation because this encourages the bowel to begin working, and prevents pneumonia, atelectasis, DVT and pulmonary embolism.

All further management DOES NOT necessarily have to follow any instructions on this leaflet as management of any case will have to be managed on a case-to-case basis. This leaflet is only meant for a good understanding of the procedure that you will undergo and possible risks and complications that may ensue

Be informed that the operation may be aborted if untoward findings and difficult dissection is faced during the operation, or any decisions are made with the safety of the patient of primary interest

Post-operative follow up:

It is imperative that you understand that you should be on a proper follow-up to identify any delayed complications, as well as life-long surveillance for recurrence and spread of your prostate cancer

I have fully understood this operation, the risks and its complications

 

Patient’s name and signature ____________

 

Next-of-kin / Dependent / Witness name, relationship and signature ______________

 

Date _________________

TURBT (Transurethral Resection of Bladder Tumor)

TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT)

The above operation is done as an inpatient procedure. The procedure involves removing your bladder tumor using an endoscope by cutting the tumor and then obtaining deeper biopsies.

There are times when random biopsies of the bladder and prostate may be necessary.

Before the procedure, the following may be done:

  1. Blood investigations will be taken as well as group and cross matching of your blood for possible transfusion.
  2. Explanation of the procedure as below

Kindly indicate to the doctor if you are allergic to any medications prior to the procedure.

Kindly indicate to the doctor if you are on any anti-platelets (aspirin, disprin, cardiprin, Plavix / clopidogrel and even warfarin) or any herbal or traditional medications as these can cause excessive bleeding during and after the operation.

Kindly indicate to the doctor if you are on pace maker as electrocautery is used during the resection.

The procedure involves:

  1. Spinal or general anaesthesia and this will be decided by your anaesthetist.
  2. Placing a resectoscope through your urethra and proceed with resection of your tumour.
  3. You will be on a catheter after your operation to facilitate continuous irrigation of your bladder to remove blood clots and prevent clot formation.
  4. Intravesical chemotherapy may be instilled into your bladder after the procedure to reduce the recurrence rates of your tumour.

The complications of the procedure include:

  1. Bleeding – you will be on catheter on continuous irrigation after the procedure
  2. Sepsis / infection – you may have fever after the operation. To prevent this, prophylactic antibiotics will be administered during the operation
  3. Bladder perforation – a small hole may be inadvertently created during resection of this tumour. If this occurs, you may be on catheter for 7-10 days
  4. Anaesthetic complications – uncommon in these days in a fit and healthy patient – this will be discussed with you by your anaesthetist.

You will be on a catheter with continuous irrigation after the operation.

If you are unsure of the above explanation, kindly inform your doctor to re-explain them.

An appointment will be given to you to see the doctor in the clinic within 1-2 weeks after the above operation.

I, the undersigned, consent for the procedure of TURBT.

By consenting to TURBT and accepting the risks outlined above, I release the urologist involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications.

RADICAL CYSTOPROSTATECTOMY (MALE)

 

RADICAL CYSTOPROSTATECTOMY, BILATERAL EXTENDED PELVIC LYMPH NODE DISSECTION, WITH INTESTINAL CONDUIT (ILEAL / COLONIC CONDUIT) / PENILE URETHRECTOMY

INFORMATION LEAFLET AND CONSENT

This is a consent and information leaflet

This is a major operation with significant morbidities and risks.

The operation is done as an in-patient hospitalization and the in-patient stay will last 2 weeks or even exceeding 4-6 weeks. Radical cystectomy with intestinal conduit is not a treatment free of any complications, even in the hands of experienced urologists.

You may require post-operative ICU stay for monitoring if necessary, and mandatory ICU stay if any risks or complications were to occur.

Before the operation the following may be done:

  1. Blood and urine investigations may be taken.
  2. Blood grouping and cross matching will be done in view of possible blood transfusion if necessary
  3. Chest x-ray and ECG may be required
  4. Consent, explanation of material risks, and explanation of the procedure as below

Kindly indicate to your doctor if you are allergic to any medications prior to the procedure

Kindly indicate to your doctor if you have any underlying medical problems or any previous operations / admissions

Kindly indicate if you are on any anti-platelets or anticoagulants (aspirin, disprin, cardiprin, Plavix / clopidogrel, heparin analogues and low molecular weight heparins, prasugrel / effient, enoxaparin / lovenox, tinzaparin / innohep, fondaparinux / arixtra, rivaroxaban / xarelto, dabigatran / pradaxa, warfarin, etc) or any herbal or traditional medications as these may cause bleeding during and after operation. The doctor will decide with you on an informed decision-making on whether, and how long, that such medications should be stopped taking into account the risk-to-benefit of the outcomes of the procedure.

This procedure involves:

  1. General anesthesia, and possibly combined with epidural anesthesia for post-operative analgesia
  2. The procedure consists of radical cystectomy (removal of your whole bladder), pelvic lymph node dissection, and intestinal diversion possibly penile urethrectomy (excision of the urethra)
  3. The intestinal diversion will consist of an intestinal conduit which will deliver your urine via a stoma bag sited at your abdomen. This is permanent.
  4. You will have stents inserted into your ureters, which we be removed at a later date
  5. There are times there may be difficulty in dissection of your bladder resulting in bleeding that may require blood transfusion
  6. You may be monitored in the HDU / ICU after the operation if necessary
  7. With the removal of your bladder, you will not be able to pass your urine in the normal way, but pass urine through a bag sited in the surface of your abdomen

What happens during the procedure?

A full general anesthetic will be used and you will be asleep throughout the procedure. In some patients, the anesthetist may also use an epidural anesthetic to minimize post-operative pain. During the operation, the bladder and the urethra (water pipe) are removed. The ureters (the tubes which drain urine from the kidneys to the bladder) are then sewn to a separated piece of small bowel which is positioned on the surface of the abdomen as an opening called a urostomy. The ends of the small bowel, from which the urostomy is isolated, are then joined together again. As part of the operation, it is usual to remove the pelvic lymph nodes and possibly the penile urethra.

Pre-operative medical optimization:

Medical optimization (i.e. hypertension, anemia, any cardiac issues and diabetes), physical exercise and cessation of smoking and drugs or alcohol abuse are all considered as preoperative conditioning measures, and is necessary before the operation

Pre-operation:

Needs IV branula and IV fluids

Bowel preparation

TED stockings

Heparin analogues / anti-coagulations (to thin the blood to prevent blood clots) will be given after operation when the risk of bleeding is less than the benefit of DVT and pulmonary embolism prevention

Pre-operative stoma siting

IV antibiotics during operation, sometimes needs to start before operation

Advised to get chewing gum for post-operative period; chewing gum has also been shown to reduce time to flatus, time to bowel movement and reduced hospital length of stay in patients undergoing bowel surgery

Prior to surgery, carbohydrate loading is recommended in non-diabetic patients to minimize the development of insulin resistance and catabolism of protein and fat stores secondary to the physiological stress response seen in patients undergoing surgery. Being a diabetic, we may not be able to administer pre-operative carbohydrate loading.

Any other procedures or treatment may be conducted if deemed necessary during the operation

 

Risks and complications of the operation:

Anesthesia complications – this will be discussed with you by your anesthetist.

Bleeding: Losses 560 ml to 3000 ml of blood or even more may occur during radical cystectomy, indicating that this type of surgery often leads to considerable loss of blood and, consequently, to blood transfusions.

Infection / Sepsis / Septicemic shock – you may have fever after the operation. To prevent this, antibiotics will be given during the operation, and at times before the operation. Antibiotics may reduce this infection risk, but cannot completely eliminate this risk.

At times, there may be high fever and chills with rigor, and even low blood pressure in spite of antibiotics. This may require intensive therapy and monitoring including ICU admission.

Rectal perforation may occur during the operation as a result of adherence of the tumor to the rectum as well as difficult dissection; with necessity for a colostomy construction (an extra stoma opening on the abdomen for faeces)

Cardiovascular and cerebrovascular events (heart attacks and strokes)

Injury to surrounding organs

Life-threatening complications, multi-organ dysfunction (including liver, kidney, respiratory failure and dysfunction), including risk of death

 

Risks and complications that can occur immediately after the operation include:

Intestinal anastomotic leak, urinary leak and urinary extravasation caused by anastomotic or reservoir leakage.

Intestinal obstruction

Paralytic ileus

Infection, sepsis, septicemic shock

Wound dehiscence (breakdown of wound)

Complications due to injury to surrounding organs

Cardiovascular and cerebrovascular events (heart attacks and strokes)

Life-threatening complications, multi-organ dysfunction (including liver, kidney, respiratory failure and dysfunction), including risk of death

Post-operative DVT (deep vein thrombosis), pulmonary embolism (can be fatal)

Pneumonia, atelectasis

Complications from pelvic lymph node dissection:

Pelvic lymphocele (lymph fluid collection)

Infected collection in pelvis, abscess collection

 

Complications from the intestinal conduit:

Urinary leak; the majority of urinary leaks can be managed conservatively. If necessary, percutaneous drainage or bilateral nephrostomies (external tubes to the kidneys) to divert urine flow might be necessary in non-draining leaks.

Breakdown of ureteric anastomosis with persistent urinary leak and extravasation

Stomal and peri / para- stomal hernia

Metabolic complications can occur, because of the prolonged contact of urine with normally functioning bowel epithelium. Additionally, the length of bowel is shortened and the resorption area is diminished.

Bowel dysfunction, malabsorption of various vitamins, acid-base imbalances, electrolyte imbalances, abnormalities in bone metabolism, formation of renal calculi, and disturbances in the kidney or liver function

Mortality rates (death rates) are reported in the modern urologic literature, with figures ranging from 0.8% to 8.3% (a population-based study has shown 30-, 60-, and 90-day mortality at 1.1%, 2.4%, and 3.9%, respectively)

Morbidity is also significant, with 90-day complication rate between 28%–64%, even in high volume medical centres.

 

Delayed complications (can occur few days to even few weeks after the operation):

Post-operative DVT (deep vein thrombosis), pulmonary embolism

Pneumonia, atelectasis

Wound dehiscence

Erectile dysfunction (inability to get an erection)

Incisional hernia

Fecal urgency, fecal leakage

Recurrent UTI (urinary tract infection)

Stomal and peri / para- stomal hernia

Metabolic complications can occur, because of the prolonged contact of urine with normally functioning bowel epithelium. Additionally, the length of bowel is shortened and the resorption area is diminished.

Bowel dysfunction, malabsorption of various vitamins, acid-base imbalances, electrolyte imbalances, abnormalities in bone metabolism, formation of renal calculi, and disturbances in the kidney or liver function

Prolonged hospital stay

Possible prolonged ICU stay

Prolonged stay resulting in financial constraints

Long term effects:

Intestinal conduit:

Infection

Recurrent urine infection

Metabolic abnormalities

Absorption abnormalities

Ureteroileal stricture (narrowing of the anastomosis between the ureters and the intestinal conduit)

Stomal stenosis

Shortening of the upper urinary tract to the conduit

Hydronephrosis (kidney swelling due to reflux of urine and / or obstruction)

Difficulty in upper tract cancer surveillance for cancer recurrence

Rarely, cancer developing at anastomosis of ureter and intestine

 

SUMMARY of Risks, Side Effects and Complications:

Common (greater than 1 in 10)

Temporary insertion of a stomach tube through the nose, a drain and ureteric stents

Erectile dysfunction (inability to get an erection)

The cancer may not necessarily be cured by the operation, depending on the stage of the disease (this will be discussed with you before and after the operation)

MRSA wound infection (1 in 10 risk)

Occasional (between 1 in 10 and 1 in 50)

Anesthetic or cardiovascular problems possibly requiring intensive care admission (including chest infection, pulmonary embolus, stroke, deep vein thrombosis, heart attack and death)

Infection in the abdominal cavity or in the wound

Blood loss requiring repeat surgery

Hernia of the incision requiring further treatment

Decrease in kidney function with time

Scarring, narrowing or hernia formation around the stomal opening requiring revision surgery

Rare (less than 1 in 50)

Diarrhea /vitamin deficiency due to shortened bowel requiring treatment

Bowel and urine leakage from the anastomosis requiring re-operation

Scarring of the bowel or ureters requiring further surgery

Intra-operative rectal injury requiring colostomy

Hospital-acquired infection

Colonization with MRSA (0.9% -1 in 110)

Clostridium difficile bowel infection (0.2% -1 in 500)

MRSA bloodstream infection (0.08% -1 in 1250)

 

Financial aspects:

This is a major operation. As of year 2019, the operation with post-operative stay may amount to Rm 60,000 to Rm 80,000 and may even exceed more than Rm 100,000 to Rm 150,000 or even more depending on number of days of stay and ICU stay.

After operation:

After operation you are not to eat or drink anything until instructed

You may be monitored and managed in the HDU / ICU post-operatively

You will have a nasogastric tube (tube from your nostrils into the stomach) which will be subsequently removed

You will be on an I.V. drip and probably on central venous line which may go through the neck veins

You will have a permanent urostomy bag to facilitate urine drainage from your abdomen.

You will have external stents from your ureter into the intestinal conduit which will be removed at a later date

You MAY have a colostomy bag to divert feces to the abdomen if there was difficult dissection during the operation or if there was a rectal perforation

You must wear your TED stockings at all times for at least 4-6 weeks, or sometimes longer, unless instructed otherwise

Heparin analogues / anti-coagulants will be started after the operation for which the time this will be instituted would depend on the risk to benefit of bleeding post-operatively versus that of preventing DVT and pulmonary embolism. You may be on this heparin analogue / anti-coagulant for 4 -6 weeks after operation, even after discharge from the hospital

You will be encouraged to mobilize as soon as possible after the operation because this encourages the bowel to begin working, and prevents pneumonia, atelectasis, DVT and pulmonary embolism.

 

All further management DOES NOT necessarily have to follow any instructions on this leaflet as management of any case will have to be managed on a case-to-case basis. This leaflet is only meant for a good understanding of the procedure that you will undergo and possible risks and complications that may ensue

Be informed that the operation may be aborted if untoward findings and difficult dissection is faced during the operation, or any decisions are made with the safety of the patient of primary interest

 

Post-operative follow up:

It is imperative that you understand that you should be on a proper follow-up to identify any delayed complications, as well as life-long surveillance for recurrence and spread of your bladder cancer

Problems with upper tract surveillance:

With the intestinal conduit, it will be difficult to scope the ureters for surveillance, and if this is so, you need to rely on CT scan and contrast imaging to detect any early cancer recurrences.

I have fully understood this operation, the risks and its complications

 

Patient’s name and signature ____________

 

Next-of-kin / Dependent / Witness name, relationship and signature ______________

 

Date _________________

RADICAL CYSTECTOMY (FEMALE)

RADICAL CYSTECTOMY, HYSTERECTOMY, EXTENDED PELVIC LYMPH NODE DISSECTION, WITH INTESTINAL CONDUIT – FEMALE

INFORMATION LEAFLET AND CONSENT

This is a consent and information leaflet.

This is a major operation with significant morbidities and risks.

The operation is done as an in-patient hospitalization and the in-patient stay will last 1-2 weeks or even exceeding 4-6 weeks. Radical cystectomy with intestinal conduit is not a treatment free of any complications, even in the hands of experienced urologists.

You may require post-operative ICU stay for monitoring if necessary, and mandatory ICU stay if any risks or complications were to occur.

Before the operation the following may be done:

  1. Blood and urine investigations may be taken.
  2. Blood grouping and cross matching will be done in view of possible blood transfusion if necessary
  3. Chest x-ray and ECG may be required
  4. Consent, explanation of material risks, and explanation of the procedure as below

Kindly indicate to your doctor if you are allergic to any medications prior to the procedure

Kindly indicate to your doctor if you are pregnant or have any underlying medical problems or any previous operations / admissions

Kindly indicate if you are on any anti-platelets or anticoagulants (aspirin, disprin, cardiprin, Plavix / clopidogrel, heparin analogues and low molecular weight heparins, prasugrel / effient, enoxaparin / lovenox, tinzaparin / innohep, fondaparinux / arixtra, rivaroxaban / xarelto, dabigatran / pradaxa, warfarin, etc) or any herbal or traditional medications as these may cause bleeding during and after operation. The doctor will decide with you on an informed decision-making on whether, and how long, that such medications should be stopped taking into account the risk-to-benefit of the outcomes of the procedure.

This procedure involves:

  1. General anesthesia, and possibly combined with epidural anesthesia for post-operative analgesia
  2. The procedure consists of radical cystectomy (removal of your whole bladder), pelvic lymph node dissection, hysterectomy (removal of your uterus), and intestinal diversion
  3. The intestinal diversion will consist of an intestinal conduit which will deliver your urine via a stoma bag sited at your abdomen. This is permanent.
  4. You will have stents inserted into your ureters, which we be removed at a later date
  5. There are times there may be difficulty in dissection of your bladder and uterus resulting in bleeding that may require blood transfusion
  6. You may be monitored in the HDU / ICU after the operation if necessary
  7. With the removal of your uterus, you will not be able to conceive or be pregnant

What happens during the procedure?

A full general anesthetic will be used and you will be asleep throughout the procedure. In some patients, the anesthetist may also use an epidural anesthetic to minimize post-operative pain. During the operation, the bladder and the urethra (water pipe) are removed. The ureters (the tubes which drain urine from the kidneys to the bladder) are then sewn to a separated piece of small bowel which is positioned on the surface of the abdomen as an opening called a urostomy. The ends of the small bowel, from which the urostomy is isolated, are then joined together again. As part of the operation, it is usual to remove the pelvic lymph nodes, uterus (womb), both ovaries (depends on intra-operative findings) and the upper part of the vagina.

Pre-operative medical optimization:

Medical optimization (i.e. hypertension, anemia, any cardiac issues and diabetes), physical exercise and cessation of smoking and drugs or alcohol abuse are all considered as preoperative conditioning measures, and is necessary before the operation

Pre-operation:

Needs IV branula and IV fluids

Bowel preparation

TED stockings

Heparin analogues / anti-coagulants (to thin the blood to prevent blood clots) will be given after operation when the risk of bleeding is less than the benefit of DVT and pulmonary embolism prevention

Pre-operative stoma siting

IV antibiotics during operation, sometimes needs to start before operation

Advised to get chewing gum for post-operative period; chewing gum has also been shown to reduce time to flatus, time to bowel movement and reduced hospital length of stay in patients undergoing bowel surgery

Prior to surgery, carbohydrate loading is recommended in non-diabetic patients to minimize the development of insulin resistance and catabolism of protein and fat stores secondary to the physiological stress response seen in patients undergoing surgery.

OPERATION: Radical cystectomy, midline incision, extended pelvic LN dissection, hysterectomy, intestinal conduit

Necessity for removal of the ovaries will be a decision made during the operation

A portion of the vagina will be removed

Any other procedures or treatment may be conducted if deemed necessary during the operation

Risks and complications of the operation:

Anesthesia complications – this will be discussed with you by your anesthetist.

Bleeding: Losses 560 ml to 3000 ml of blood or even more may occur during radical cystectomy, indicating that this type of surgery often leads to considerable loss of blood and, consequently, to blood transfusions.

Infection / Sepsis / Septicemic shock – you may have fever after the operation. To prevent this, antibiotics will be given during the operation, and at times before the operation. Antibiotics may reduce this infection risk, but cannot completely eliminate this risk.

At times, there may be high fever and chills with rigor, and even low blood pressure inspite of antibiotics. This may require intensive therapy and monitoring including ICU admission.

Rectal perforation may occur during the operation as a result of adherence of the tumor to the rectum as well as difficult dissection; with necessity for a colostomy construction (an extra stoma opening on the abdomen for faeces)

Cardiovascular and cerebrovascular events (heart attacks and strokes)

Injury to surrounding organs

Life-threatening complications, multi-organ dysfunction (including liver, kidney, respiratory failure and dysfunction), including risk of death

Risks and complications that can occur immediately after the operation include:

Intestinal anastomotic leak, urinary leak and urinary extravasation caused by anastomotic or reservoir leakage.

Intestinal obstruction

Paralytic ileus

Infection, sepsis, septicemic shock

Wound dehiscence (breakdown of wound)

Complications due to injury to surrounding organs

Cardiovascular and cerebrovascular events (heart attacks and strokes)

Life-threatening complications, multi-organ dysfunction (including liver, kidney, respiratory failure and dysfunction), including risk of death

Post-operative DVT (deep vein thrombosis), pulmonary embolism (can be fatal)

Pneumonia, atelectasis

Complications from pelvic lymph node dissection:

Pelvic lymphocele (lymph fluid collection)

Infected collection in pelvis, abscess collection

Complications from the intestinal conduit:

Urinary leak; the majority of urinary leaks can be managed conservatively. If necessary, percutaneous drainage or bilateral nephrostomies (external tubes to the kidneys) to divert urine flow might be necessary in non-draining leaks.

Breakdown of ureteric anastomosis with persistent urinary leak and extravasation

Stomal and peri / para- stomal hernia

Metabolic complications can occur, because of the prolonged contact of urine with normally functioning bowel epithelium. Additionally, the length of bowel is shortened and the resorption area is diminished.

Bowel dysfunction, malabsorption of various vitamins, acid-base imbalances, electrolyte imbalances, abnormalities in bone metabolism, formation of renal calculi, and disturbances in the kidney or liver function

Mortality rates (death rates) are reported in the modern urologic literature, with figures ranging from 0.8% to 8.3% (a population-based study has shown 30-, 60-, and 90-day mortality at 1.1%, 2.4%, and 3.9%, respectively)

Morbidity is also significant, with 90-day complication rate between 28%–64%, even in high volume medical centres.

Delayed complications (can occur few days to even few weeks after the operation):

Post-operative DVT (deep vein thrombosis), pulmonary embolism

Pneumonia, atelectasis

Wound dehiscence

Sexual dysfunction: Pain on sex, dyspareunia (pain on sex) due to short vagina, reduced vaginal lubrication caused by damage to autonomic nerves originating from the hypogastric plexus, inability to have orgasms, decreased sexual desire.

Incisional hernia

Fecal urgency, fecal leakage

Recurrent UTI (urinary tract infection)

Stomal and peri / para- stomal hernia

Metabolic complications can occur, because of the prolonged contact of urine with normally functioning bowel epithelium. Additionally, the length of bowel is shortened and the resorption area is diminished.

Bowel dysfunction, malabsorption of various vitamins, acid-base imbalances, electrolyte imbalances, abnormalities in bone metabolism, formation of renal calculi, and disturbances in the kidney or liver function

Prolonged hospital stay

Possible prolonged ICU stay

Prolonged stay resulting in financial constraints

Long term effects:

Intestinal conduit:

Infection

Recurrent urine infection

Metabolic abnormalities

Absorption abnormalities

Ureteroileal stricture (narrowing of the anastomosis between the ureters and the intestinal conduit)

Stomal stenosis

Shortening of the upper urinary tract to the conduit

Hydronephrosis (kidney swelling due to reflux of urine and / or obstruction)

Difficulty in upper tract cancer surveillance for cancer recurrence

Rarely, cancer developing at anastomosis of ureter and intestine

 

SUMMARY of Risks, Side Effects and Complications:

Common (greater than 1 in 10)

Temporary insertion of a stomach tube through the nose, a drain and ureteric stents

Discomfort or difficulty with sexual intercourse due to narrowing or shortening of vagina

In the event of removal of the ovaries, menopause may occur

The cancer may not necessarily be cured by the operation, depending on the stage of the disease (this will be discussed with you before and after the operation)

MRSA wound infection (1 in 10 risk)

Occasional (between 1 in 10 and 1 in 50)

Anesthetic or cardiovascular problems possibly requiring intensive care admission (including chest infection, pulmonary embolus, stroke, deep vein thrombosis, heart attack and death)

Infection in the abdominal cavity or in the wound

Blood loss requiring repeat surgery

Hernia of the incision requiring further treatment

Decrease in kidney function with time

Scarring, narrowing or hernia formation around the stomal opening requiring revision surgery

Rare (less than 1 in 50)

Diarrhea /vitamin deficiency due to shortened bowel requiring treatment

Bowel and urine leakage from the anastomosis requiring re-operation

Scarring of the bowel or ureters requiring further surgery

Intra-operative rectal injury requiring colostomy

Hospital-acquired infection

Colonization with MRSA (0.9% -1 in 110)

Clostridium difficile bowel infection (0.2% -1 in 500)

MRSA bloodstream infection (0.08% -1 in 1250)

Financial aspects:

This is a major operation. As of year 2019, the operation with post-operative stay may amount to Rm 40,000 to Rm 50,000 and may even exceed more than Rm 60,000 to Rm 80,000 or even more depending on number of days of stay and ICU stay.

After operation:

After operation you are not to eat or drink anything until instructed

You may be monitored and managed in the HDU / ICU post-operatively

You will have a nasogastric tube (tube from your nostrils into the stomach) which will be subsequently removed

You will be on an I.V. drip and probably on central venous line which may go through the neck veins

You will have a permanent urostomy bag to facilitate urine drainage from your abdomen.

You will have external stents from your ureter into the intestinal conduit which will be removed at a later date

You MAY have a colostomy bag to divert feces to the abdomen if there was difficult dissection during the operation or if there was a rectal perforation

You must wear your TED stockings at all times for at least 4-5 weeks, or sometimes longer, unless instructed otherwise

Heparin analogues / anti-coagulants will be started after the operation for which the time this will be instituted would depend on the risk to benefit of bleeding post-operatively versus that of preventing DVT and pulmonary embolism

You will be encouraged to mobilize as soon as possible after the operation because this encourages the bowel to begin working, and prevents pneumonia, atelectasis, DVT and pulmonary embolism.

 

All further management DOES NOT necessarily have to follow any instructions on this leaflet as management of any case will have to be managed on a case-to-case basis. This leaflet is only meant for a good understanding of the procedure that you will undergo and possible risks and complications that may ensue

Be informed that the operation may be aborted if untoward findings and difficult dissection is faced during the operation, or any decisions are made with the safety of the patient of primary interest

Post-operative follow up:

It is imperative that you understand that you should be on a proper follow-up to identify any delayed complications, as well as life-long surveillance for recurrence and spread of your bladder cancer

Problems with upper tract surveillance:

With the intestinal conduit, it will be difficult to scope the ureters for surveillance, and if this is so, you need to rely on CT scan and contrast imaging to detect any early cancer recurrences.

 

I have fully understood this operation, the risks and its complications

 

Patient’s name and signature ____________

 

Next-of-kin / Dependent / Witness name, relationship and signature ______________

 

Date _________________

 

Laparoscopic Nephrectomy / Nephroureterectomy

LAPAROSCOPIC NEPHROURETERECTOMY

The above operation is done as an inpatient procedure.

Before the procedure, the following may be done:

  1. Blood investigations will be taken. Blood grouping and cross matching will be done in view of possible blood transfusion.
  2. Explanation of the procedure as below

Kindly indicate to the doctor if you are allergic to any medications prior to the procedure.

Kindly indicate to the doctor if you are pregnant or have any other underlying medical problems or any previous operations / admissions.

Kindly indicate to the doctor if you are on any anti-platelets (aspirin, disprin, cardiprin, plavix / clopidogrel and even warfarin) or any herbal or traditional medications as these may cause bleeding during and after the operation. These medications should be stopped at least 7 days before the operation.

The procedure involves:

  1. General anaesthesia and this will be explained to you by your anaesthetist.
  2. Generally 3-4 small incisions (0.5-1 cm) will be placed over your abdomen to facilitate this laparoscopic surgery (key-hole surgery). A laparoscope will then be inserted into your abdomen and carbon dioxide will be insufflated followed by port placement. Your kidney will then be dissected via these key-hole incisions. A larger incision will then be placed at your lower abdomen to remove this kidney. Through this same incision, your ureter will be dissected and removed with a cuff of bladder.
  3. There are times when there may be difficulty in dissection of the kidney, adhesions or excessive bleeding. If these were to occur, then this laparoscopic procedure will be aborted and a large incision will be placed on the abdomen to remove your kidney (open conversion).
  4. You may be on a catheter (7-10 days) and abdominal drain after the procedure. You may be monitored in the HDU / ICU after the operation for possible bleeding post-operatively.

The complications of the procedure include:

  1. Bleeding: this may require immediate termination of the laparoscopic procedure and an incision will be placed on the abdomen to remove your kidney (open conversion). You may require blood transfusion if there is significant bleeding.
  2. Sepsis / infection – you may have fever after the operation. To prevent this, prophylactic antibiotics will be administered during the operation. At times there may be high fever with chills and rigor in spite of the antibiotics and this may require intensive therapy and monitoring and possibly ICU admission.
  3. Perforation of the bowel or surrounding organs may occur and this may require open conversion.
  4. If there is injury of your pleura (lung layer) you may require a chest tube.
  5. At times, injury to the surrounding organs may occur as a result of thermal (burn) or electrical injury and this may not be identified immediately after the operation. If you do experience abdominal distension (bloating), pain or fever even 7-10 days after discharge, kindly inform your doctor immediately.
  6. If you have borderline kidney function, you may have kidney failure after removal of your kidney.
  7. You may develop subcutaneous emphysema (air bubbles under the skin). This will usually resolve spontaneously.
  8. Anaesthetic complications – uncommon I these days in a fit and healthy patient – this will be discussed with you by your anaesthetist.

An appointment will be given to you to see doctor in the clinic after the above operation.

I, the undersigned, consent for the procedure of laparoscopic nephroureterectomy or its related procedure. There may be a possibility of open conversion in the event of any difficulties.

By consenting to laparoscopic nephroureterectomy or its related procedure and accepting the risks outlined above, I release the urologist and the assistants involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications

Partial Nephrectomy

PARTIAL NEPHRECTOMY

The above operation is done as an inpatient procedure.

Before the procedure the following may be done:

  1. Blood investigations will be taken. Blood grouping and cross matching will be done in view of possible blood transfusion if required.
  2. Explanation of the procedure as below

Kindly indicate to the doctor if you are allergic to any medications prior to the procedure.

Kindly indicate to the doctor if you are pregnant or have any other underlying medical problems or any previous operations / admissions.

Kindly indicate to the doctor if you are on any anti-platelets (aspirin, disprin, cardiprin, Plavix / clopidogrel and even warfarin) or any herbal or traditional medications as these may cause bleeding during and after the operation. These medication should be stopped at least 7 days before the operation.

The procedure involves:

  1. General anaesthesia and this will be explained to you by your anaesthetist.
  2. You may require replacement of a ureteric catheter (placement of a tube in the ureter) to assess the kidney system for any possible urinary leaks after partial nephrectomy.
  3. An incision will be placed at your loin or abdomen. The surrounding kidney will be dissected and evaluated to see whether it is feasible enough to proceed with partial nephrectomy.
  4. There are times when there may be difficulty in dissection of the kidney, adhesions or excessive bleeding. There are also times when there would be difficulty in proceeding with partial nephrectomy. If these were to occur, then removal of the whole kidney would be considered.
  5. You may be on a catheter and abdominal drain after the procedure. You may be monitored in the HDU/ICU after the operation if necessary.

The complication of the procedure include:

  1. Bleeding: this may require blood transfusion if there is significant bleeding. At times removal of your whole kidney should be considered.
  2. Sepsis / infection – you may have fever after the operation. To prevent this, prophylactic antibiotics will be administered during the operation. At times there may be high fever with chills and rigor in spite of this antibiotics and this may require intensive therapy and monitoring and possibly ICU admission.
  3. Urine leak approximately 10 % – there are times when partial nephrectomy will have to include the pelvicalyceal system (urinary communication in the kidney) which may result in urine leak. If this urine leak occurs, you may require ureteric stenting (internal tube placement in your kidney and ureter), continuation of your abdominal drain and a prolonged stay in the ward. The ureteric stent (tube) will then be removed at a later date. Kindly note that this stent cannot be kept permanently and must be removed within 3 months after its insertion. The date for the stent removal will be given to you by your doctor.
  4. If there is injury of your pleura (lung layer), you may require a chest tube.
  5. Perforation of the bowel or surrounding organs may occur and this may require colostomy or repair.
  6. If you have borderline kidney function, you may have kidney failure after removal of your kidney.
  7. Anaesthetic complications – uncommon in these days in a fit and healthy patient – this will be discussed with you by your anaesthetist.

An appointment will be given to you to see the doctor in the clinic after the above operation.

I, the undersigned, consent for the procedure of partial nephrectomy or its related procedure. There may be a possibility of nephrectomy (removal of the whole kidney) if partial nephrectomy is unsuitable or in the event of any difficulties. By consenting to partial nephrectomy or its related procedure and accepting the risks outline above, I release the urologist and the assistants involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications.

TVT Sling

TVT SLING PROCEDURE – CONSENT

The above procedure is done as an inpatient or day-care procedure.

Before the procedure, the following may be done

  1. Blood investigations may be taken
  2. Suprapubic shaving may be done
  3. Explanation of the procedure as below

Kindly indicate to the doctor if you are allergic to any medications prior to the procedure

Kindly indicate to the doctor if you are pregnant

Kindly indicate to the doctor if you have had previous abdominal surgeries or have any hip pain, deformity or hip surgeries; or if you have an inguinal hernia (need repair before the sling procedure).

Kindly indicate to the doctor if you are on any anti-platelets (aspirin, disprin, cardiprin, plavix / clopidogrel and even warfarin) or any herbal or traditional medications as these may cause bleeding during and after the operation. These medications should be stopped at least 10 days before operation.

The above procedure may not be suitable for future pregnancy planning.

The procedure involves:

  1. Local, regional or general anaesthesia and this will be explained to you by your anaesthetist. Regional anaesthesia may be preferable.
  2. Inserting a cystoscope (endoscope instrument) into your bladder followed by small incisions on your abdomen and vagina.
  3. A tape will then be placed around your urethra using large needles so as to cause slight compression of the urethra to prevent leakage of urine. You may be asked to cough to assess the tightness of the tape and assessment of the leakage
  4. You may be on a urethral catheter after the procedure.

The procedure may be last 60 minutes and consist of:

    Two miniature incisions over the abdomen

    A small incision in your vagina

    85 – 90% cure rate of incontinence

The complications of the procedure include:

  1. Bladder perforation (0-6%)
  2. Blood loss > 500 mL (1-2%)
  3. Urinary retention (2-10%)
  4. Pelvic haematoma / blood collection (1-2%)

Late complications include:

  1. De novo urgency – sensation of needing to pass urine regularly (15-20%)
  2. Recurrent urinary tract infection (5-10%)
  3. Persistent suprapubic discomfort (5-10%)
  4. Tape erosion into bladder (0-5%)
  5. Tape erosion into the vagina (0-2%)
  6. Bowel injury – rare
  7. Nerve injury – rare
  8. Major vessel injury – rare

The procedure may be aborted if there is a foreseeable complication. If there is perforation, you may be on a urethral catheter for a while.

If you are unsure of the above explanation, kindly inform your doctor to re-explain them

An appointment will be given to you to see the doctor in the clinic after the above operation.

I, the undersigned, consent for the procedure of TVT sling or its related procedure. By consenting to TVT sling or its related procedure and accepting the risks outlined above, I release the urologist involved from liability for time lost from work salary unearned, and medical expenses incurred to treat complications.

Radical Orchidectomy

RADICAL ORCHIDECTOMY

The above procedure is done as an in-patient or daycare procedure.

The procedure involves removing your testis along a groin (inguinal) incision.

Before the procedure, the following may be done:

  1. Blood investigations may be taken to assess for tumour markers
  2. Counselling on sperm banking
  3. Counselling on testicular prosthesis

Kindly indicate to your doctor if you are interested in the sperm banking or testicular prosthesis

Kindly indicate to the doctor if you are allergic to any medication prior to the procedure.

The procedure involves:

  1. Spinal or general anaesthesia, and at times may also be done under local anaesthesia
  2. An incision placed over your groin (inguinal region) after shaving that area.
  3. Removal of your testis

The complications of the procedure include:

  1. Pain / discomfort
  2. Wound infection – fever , red discoloration of the wound, pus discharge
  3. Hematoma (swelling due to blood collection) of your groin and /or scrotum

If you do have the above complications after discharge from the hospital, then please come back immediately to the clinic, or to the emergency department after office hours.

An appointment will be given to you to see the doctor in the clinic within a week after the above procedure to evaluate the pathology results

I, the underdesigned, consent for the procedure of radical orchidectomy.

By consenting to radical orchidectomy and accepting the risks outlined above, I release the urologist involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications.

I have also been counseled on sperm banking and testicular prosthesis

Urethroplasty

URETHROPLASTY

The above operation is done as an inpatient procedure. The procedure involves placing you in a lithothomy position and an incision will be placed in your perineum to access your urethra for reconstruction. The suprapubic tract will be accessed via dilators and scopes. There may be a possibility that your abdomen may be opened in complex cases and that buccal mucosa (inner oral cavity lining) may be incised to obtain a graft for reconstruction of your urethra.

Before the procedure, the following may be done:

  1. Clinical assessment of the penile skin, perineum, ability of hip flexion and oral cavity examination will be done
  2. Blood investigations will be taken as well as group and cross matching of your blood for possible blood transfusion
  3. Review urethrogram films
  4. Urine culture before the procedure
  5. Antibiotics pre-operatively if required
  6. Perineal and suprapubic cleansing pre-operatively
  7. Shaving of the suprapubic region and the perineum
  8. Oral cavity and dental with mouth wash / gargle in view of buccal mucosal substitution graft

 Kindly indicate to the doctor if you are allergic to any medications prior to the procedure.

 Kindly indicate to the doctor if you are on any anti-platelets (aspirin, disprin, cardiprin, Plavix / clopidogrel and even warfarin) or any herbal or traditional medications as these can cause excessive bleeding during and after the operation.

The procedure involves:

  1. General anaesthesia and this will be explained to you by your anaesthetist. You may require post-operative epidural analgesia for relief of pain after operation.
  2. Flexible cysto-urethroscopy assessment will be done to assess the extent of your stricture.
  3. An incision will be done in your perineum, the urethra will be dissected and urethral reconstruction will be done
  4. Your pubic bone may be partially excised to obtain length for your urethral reconstruction
  5. Your abdomen may be opened in complex cases for a combined abdomino-perineal approach if required
  6. An incision may be required in your oral cavity (mouth) if buccal mucosal graft is required for substitution
  7. You will be on urethral and suprapubic catheters after your operation
  8. You may be on heparin post-operatively to prevent calf vein thrombosis while immobilized.

Post operatively you may require:

  1. Bed rest for a few days
  2. You will be on urethral and suprapubic catheters for 10-21 days
  3. Peri-catheter urethrogram will be required after 10-21 days, followed by uroflowmetry

The complications of the procedure include:

  1. Bleeding – requiring blood transfusion in approximately 5-10% of cases
  2. Sepsis / infection – you may have fever after the operation. To prevent this, prophylactic antibiotics will be administered during the operation. If severe sepsis occurs, you may require monitoring and treatment in the ICU
  3. Erectile dysfunction / impotence – 5%. However you may have this even before the operation as a result of the severity of your injury
  4. Total incontinence – continuous leaking of urine – as a result of a sphincteric stricture (stricture at the sphincter) or an injury of the sphincter sustained during your trauma. This may require urethral catheter or an artificial sphincter operation 1 year later
  5. Anaesthetic complication – uncommon in these days in a fit and healthy patient – this will be discussed with you by your anaesthetist
  6. Other non-specific complications of prolonged stay and immobilization

If you are unsure of the above explanation, kindly inform your doctor to re-explain them.

I, the undersigned, consent for the procedure of URETHROPLASTY

By consenting to URETHROPLASTY and accepting the risks outlined above, I release the urologist involved from liability for time lost from work, salary unearned, and medical expenses incurred to treat complications.

I have also been counseled on erectile dysfunction, incontinence, pubic bone excision, abdominal exploration, oral cavity (mouth) incision for buccal mucosal graft and the possibility of recurrence of the urethral stricture.