A Study to Determine if Mesh Placement During Bladder Surgery Can Reduce the Chances of Developing a Hernia

The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.

Completed

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Key information

Conditions

Radical Cystectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing RC and IC formation in an elective setting,for cancer.

Exclusion criteria

Expected survival < 12 months
Salvage RC
Distant metastatic disease

Treatment and study plan

Surgery Radical Cystectomy

Procedure

All surgeries will be performed in an open or laparoscopic fashion.

Ultrapro mesh

Procedure

Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.

Primary outcomes

Number of patients with incidence of radiographic Parastomal Hernia

Time frame: within 2 years of RC and IC.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Prospective, Randomized Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Sep 20, 2016
Registry last updated: Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed