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MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

NCT04391790 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-04-27

No results posted yet for this study

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

Interventions

PROCEDURE

Cystectomy and modified urinary conduit

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.

PROCEDURE

Cystectomy and standard urinary conduit ad modum Bricker

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.

Sponsors & Collaborators

  • Jørgen Bjerggaard Jensen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391790 on ClinicalTrials.gov