MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy (MOSAIC)

Jørgen Bjerggaard Jensen

Status: Active, not recruiting

Conditions: Bladder Cancer

Treatments: Procedure: Cystectomy and modified urinary conduit; Procedure: Cystectomy and standard urinary conduit ad modum Bricker

Study type: Interventional

Funder types: Other

Identifiers

NCT04391790

DaBlaCa-16 (Other Identifier)

MOSAIC

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Control

Active Comparator group

Description:

Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker

Treatment:

Procedure: Cystectomy and standard urinary conduit ad modum Bricker

Intervention

Experimental group

Description:

Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit

Treatment:

Procedure: Cystectomy and modified urinary conduit