Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center

Study Overview
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Brief Summary
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This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.

Detailed Description
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The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.

Official Title
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Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center

Conditions
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Bladder Cancer, Laparoscopy

Intervention / Treatment
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* Procedure: Open radical cystectomy
* Procedure: Laparoscopic-assisted radical cystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma. Patients fit for surgery (ECOG Performance Status 0,1). Exclusion Criteria: Patients with medical comorbidities that preclude surgical management or minimally invasive techniques. Patients with advanced hydronephrosis or renal failure. Patients refusing surgery. Patients with urinary bladder cancer invading bladder neck or prostatic urethra. Patients with metastatic urinary bladder cancer. Patients who received prior pelvic radiotherapy. Patients refusing randomization and/or participation in the trial.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Radical Cystectomy<br>Standard open radical cystectomy. | Procedure: Open radical cystectomy<br>* Standard open radical cystectomy and urinary diversion<br>|
| Experimental: Laparoscopic-assisted radical cystectomy.<br>Laparoscopic-assisted radical cystectomy. | Procedure: Laparoscopic-assisted radical cystectomy<br>* Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion. | During surgery | 
| Blood loss | EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs. | During surgery | 
| Length of hospital stay | LOS as measured in days | Immediate post-operative period. | 
| Time to oral intake | Measured in days | Immediate post-operative period | 
| Conversion rate | Rate of conversion from laparoscopy to open surgery | During surgery | 
| Re-admission rate. | Re-hospitalization requirement. | Intra-operative to sixth months. | 
| Opioid requirements. | Requirement, dose and duration of narcotic analgesia. | During surgery through first post-operative week. | 
| Visceral injury | Any organ injury encountered during the operation. | During surgery | 
| Urine leak | Leakage of urine from urinary enteric anastomosis | Up to 4 weeks | 
| Wound dehiscence, infection. | Wound gaping, evisceration or infection. | Up to 4 weeks | 
| Enteric fistula | Leakage of intestinal contents due to failure of entero-enteric anastomosis | Up to 4 weeks | 
| Sepsis | Infection triggering a systematic immune response | Up to 4 weeks | 
| Venous thromboembolism | DVT or pulmonary embolism | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pT stage | Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4) | Within 10 days post surgery. | 
| Lymph node retrieval | Number of lymph nodes retrieved by open versus laparoscopic approaches. | Within 10 days post surgery. | 
| pN stage | Lymph node metastasis (positive or negative), and number of positive nodes if present. | Within 10 days post surgery. | 
| Surgical margins | Positive margins or negative margins. Location of positive margins (Urethral, ureteric) | Within 10 days post surgery | 
| Histological grade | Low grade, intermediate grade or high grade | Within 10 days post surgery |