Open Versus Laparoscopic Radical Cystectomy

Phase 2

• Conditions: Bladder Cancer
• Interventions: Procedure: Open radical cystectomy with open urinary diversion; Procedure: Laparoscopic radical cystectomy with open urinary diversion

• Registration Number: NCT02345499
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-19
• Last Update Submitted: 2015-01-19
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-26
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1. Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder
2. Patients with an indication to ureterocutaneostomy or ileal conduit
3. ECOG Performance Status ≤ 2
4. 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

1. 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)
2. Patients who have previously received any pelvic irradiation
3. Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
4. Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
5. Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open radical cystectomy	Open radical cystectomy with open urinary diversion	Surgery: Open radical cystectomy with open urinary diversion
Laparoscopic radical cystectomy	Laparoscopic radical cystectomy with open urinary diversion	Surgery: Laparoscopic radical cystectomy with open urinary diversion

Primary Outcome Measures

Name	Time	Method
Complication rate	24 months	Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	24 months	Comparison of health related quality of life among the two cohorts under investigation according to the SF-36 questionnaire

Trial Locations

Locations (1)

Vincenzo Pagliarulo; 🇮🇹 Bari, Italy