MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

NCT04391790 | Unknown

• 2 other identifiers: MOSAICDaBlaCa-16
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Bladder Cancer

Keywords

ureteral strictures; urinary diversion

Outcome Measures

Primary Outcomes (1)

• Strictures

  Number of participants with benign strictures in the left ureter

  Within 2 years after cystectomy

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: Cystectomy and standard urinary conduit ad modum Bricker

Intervention

EXPERIMENTAL

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

Procedure: Cystectomy and modified urinary conduit

Interventions

Cystectomy and modified urinary conduit PROCEDURE

The modified retrosigmoid conduit is extended aorund 5 cm, so the left ureter does not have to cross under the mesentery wheras the presumed more robust ileal segment does.

Also known as: Retrosigmoid conduit

Intervention

Cystectomy and standard urinary conduit ad modum Bricker PROCEDURE

The conduit is constructed using approximately 15 cm of terminal ileum and placed in the right side of the abdomen. In order for the left ureter to reach the conduit, it is mobilized behind the sigmoideum to the conduit.

Also known as: Conventional ileal conduit

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Jørgen Bjerggaard Jensen: lead

Study Sites (5)

Department of Urology, Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Department of Urology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Urology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Urology, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

Location

Department of Urology, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Consultant, MD, DMSc

Model Details: A prospective, multicenter, randomized clinical trial

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: May 27, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

DK (5)