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Informed Consent For Surgical Operation / Procedure
Procedure: Robot-assisted/Open Radical Cystectomy + Ileal Conduit + Bilateral Standard Pelvic Lymph Node Dissection
1. Patient Identification
I, ______________________________ (patient/next of kin/legal guardian), aged ____ years, in my full senses, voluntarily authorize and give my complete consent for performance of the following procedure(s)/operation(s)/treatment(s):
Procedure: _______________________________
Diagnosis: ________________________________
Major illness & comorbidities: ________________________________
2. Authorization for Procedure
I authorize Dr. __________________ to perform the above procedure, along with such assistants and associates as may be selected by him/her.
I understand that members of the surgical team, including residents or trainees under appropriate supervision, may perform parts of the procedure according to their training and competence.
3. Nature of Procedure
The operation involves:
- Removal of the urinary bladder and surrounding tissues
- In males, removal of the prostate and seminal vesicles as applicable
- In females, removal of the uterus/anterior vaginal wall as applicable
- Bilateral pelvic lymph-node dissection
- Creation of an ileal conduit using a segment of intestine
- Bringing the conduit out as a stoma on the abdominal wall
- Continuous drainage of urine into an external collection bag
4. Benefits and Indications
The procedure may be performed for appropriate bladder cancer requiring removal of the urinary bladder.
The intended benefits include:
- Removal of bladder cancer with curative intent where feasible
- Prevention of disease progression/spread
- Relief of haematuria, pain and obstruction
Cancer recurrence may still occur despite surgery.
5. Risks and Complications
- General Risks
- Bleeding requiring transfusion
- Wound, urinary or systemic infection
- Pain and fever
- DVT/PE
- Myocardial infarction
- Stroke
- Anaesthetic complications, including rare death
- Procedure-specific Risks
- Injury to bowel, ureters, blood vessels or nerves
- Urinary leak
- Ileus
- Bowel obstruction
- Bowel leak/fistula
- Stomal retraction, prolapse or stenosis
- Skin irritation/infection
- Uretero-ileal stricture
- Kidney damage/deterioration of renal function
- Lymphocele
- Sexual dysfunction
- Infertility
- Need for re-operation
- Long Term Risks
- Metabolic abnormalities related to use of bowel
- Chronic kidney disease
- Lifelong dependence on a stoma appliance
- Cancer recurrence
The surgery may need conversion from robotic to open surgery, and additional procedures such as ileostomy or bilateral nephrostomy may become necessary.
6. Postoperative Course
I understand that:
- ICU care may be required
- Multiple tubes/drains and the stoma will be present
- Hospital stay: approximately 7–14 days, variable
- Recovery may take approximately 4–8 weeks
- Lifelong stoma care is required
7. Alternatives to Procedure
I have been informed of alternatives including:
- Bladder preservation with TURBT + chemotherapy + radiotherapy
- Radical cystectomy with neobladder or another urinary diversion
- Palliative chemotherapy/immunotherapy
- No treatment
8. Anaesthesia and Pain Management
I understand the risks associated with local, regional, or general anaesthesia.
Pain management options have been explained.
9. Photography / Data Use
I consent to:
☐ Medical photography/video for academic purposes
☐ Use of anonymized clinical data
10. Intraoperative Decision Consent
I authorize the surgeon to perform additional procedures considered necessary if unexpected findings arise during surgery.
11. Team-Based Care
I understand that supervised residents, fellows, or assistants may participate.
12. Patient Statement
I confirm that:
- The nature of surgery has been explained.
- Risks, benefits, and alternatives have been explained.
- My questions have been answered satisfactorily.
- I voluntarily consent.
Patient to write in own handwriting:
“I have understood the procedure, risks, benefits and alternatives explained to me in a language I understand.”
Signatures
Patient Name & Signature: ______________________________________
Date: ____________________ Time: ____________________
Doctor Name & Signature: ______________________________________
Date: ____________________ Time: ____________________
Witness Name & Signature: ____________________________________
Contact No.: ______________________________
ATTENDANT CONSENT (If applicable)
Reason patient unable to consent:
Attendant Name: __________________________________________
Relationship: _____________________________________________
Signature: ________________________________________________
Contact No.: ______________________________________________
INTERPRETER STATEMENT (If applicable)
I confirm an accurate explanation in understandable language.
Name: _________________________________________________
Signature: ______________________________________________
Contact: ________________________________________________
HIGH-RISK CONSENT (If applicable)
High-risk factors explained due to:
Patient Signature: ________________________________________
Doctor Signature: _________________________________________
