Open Versus Laparoscopic Radical Cystectomy

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02345499

Acronym

OvsL

Enrollment

Registered

2015-01-26

Start date

2014-01-31

Completion date

2016-01-31

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Radical cystectomy, Laparoscopy

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.

Interventions

PROCEDURELaparoscopic radical cystectomy with open urinary diversion

Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed

PROCEDUREOpen radical cystectomy with open urinary diversion

Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

70 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactVincenzo VP Pagliarulo, M.D.

vpagliarulo@urologia.uniba.it+39 080 5595228

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026