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

March 25, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent and Follow-Up only)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent and follow-up only)
    • New York
      • Commack, New York, United States
        • Memorial Sloan Kettering Commack (Consent and follow-up only)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Consent and follow-up only)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Consent only and Follow Up)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery (Usual approach group)
standard surgery
Procedure: Surgery Radical Cystectomy
All surgeries will be performed in an open or laparoscopic fashion.
Experimental: Surgery + Mesh Placement
prophylactic mesh at the time of standard surgery
Procedure: Surgery Radical Cystectomy
All surgeries will be performed in an open or laparoscopic fashion.
Procedure: Ultrapro mesh
Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with incidence of radiographic Parastomal Hernia
Time Frame: within 2 years of RC and IC.
within 2 years of RC and IC.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Bernard Bochner, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimated)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1285

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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