MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

Not Applicable

Active, not recruiting

• Conditions: Bladder Cancer
• Interventions: Procedure: Cystectomy and modified urinary conduit; Procedure: Cystectomy and standard urinary conduit ad modum Bricker

• Registration Number: NCT04391790
• Lead Sponsor: Jørgen Bjerggaard Jensen

Brief Summary

Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker).

Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion.

A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-18
• Study Start: 2020-05-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Bladder cancer with the indication for robot assisted radical cystectomy
• Ileal conduit ad modum Bricker as planned urinary diversion
• Ability to understand the participant information orally and in writing
• Signed consent form

Exclusion Criteria

• Previous abdominal or pelvic radiotherapy
• Previous major abdominal surgery involving resection of bowel or construction of an enteric stoma
• Urostomy planned on the left side of the abdomen
• Single kidney
• Complete ureteral duplication (either uni- or bilaterally), known at time of inclusion
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Cystectomy and modified urinary conduit	Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit
Control	Cystectomy and standard urinary conduit ad modum Bricker	Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker

Primary Outcome Measures

Name	Time	Method
Strictures	Within 2 years after cystectomy	Number of participants with benign strictures in the left ureter

Trial Locations

Locations (5)

Department of Urology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Urology, Odense University Hospital; 🇩🇰 Odense, Denmark

Department of Urology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Urology, Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark

Department of Urology, Rigshospitalet; 🇩🇰 København, Denmark