Open Versus Laparoscopic Radical Cystectomy

Study Overview
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Brief Summary
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To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.

Official Title
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Open Versus Laparoscopic Radical Cystectomy for Invasive Bladder Cancer in the Elderly Patient. A Multicenter Randomized Clinical Trial.

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Laparoscopic radical cystectomy with open urinary diversion
* Procedure: Open radical cystectomy with open urinary diversion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder Patients with an indication to ureterocutaneostomy or ileal conduit ECOG Performance Status ≤ 2 WBC count ≥4,000/μL; platelet count ≥150,000/μL 4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC Exclusion Criteria: Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit) Patients who have previously received any pelvic irradiation Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy) Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Male

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic radical cystectomy<br>Surgery: Laparoscopic radical cystectomy with open urinary diversion | Procedure: Laparoscopic radical cystectomy with open urinary diversion<br>* Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed<br>|
| Active Comparator: Open radical cystectomy<br>Surgery: Open radical cystectomy with open urinary diversion | Procedure: Open radical cystectomy with open urinary diversion<br>* Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Comparison of health related quality of life among the two cohorts under investigation according to the SF-36 questionnaire | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical cystectomy, Laparoscopy