Open Versus Laparoscopic Radical Cystectomy (OvsL)

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status and phase: Unknown; Phase 2

Conditions: Bladder Cancer

Treatments: Procedure: Laparoscopic radical cystectomy with open urinary diversion; Procedure: Open radical cystectomy with open urinary diversion

Study type: Interventional

Funder types: Other

Identifiers

NCT02345499

4201

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Laparoscopic radical cystectomy

Experimental group

Description:

Surgery: Laparoscopic radical cystectomy with open urinary diversion

Treatment:

Procedure: Laparoscopic radical cystectomy with open urinary diversion

Open radical cystectomy

Active Comparator group

Description:

Surgery: Open radical cystectomy with open urinary diversion

Treatment:

Procedure: Open radical cystectomy with open urinary diversion