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

NCT ID: NCT02908061

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Radical Cystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Surgery (Usual approach group)

standard surgery

Group Type ACTIVE_COMPARATOR

Surgery Radical Cystectomy

Intervention Type PROCEDURE

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

Surgery + Mesh Placement

prophylactic mesh at the time of standard surgery

Group Type EXPERIMENTAL

Surgery Radical Cystectomy

Intervention Type PROCEDURE

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

Ultrapro mesh

Intervention Type PROCEDURE

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

Interventions

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Surgery Radical Cystectomy

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

Intervention Type PROCEDURE

Ultrapro mesh

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard Bochner, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth (Consent and follow-up only)

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (Consent and follow-up only)

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Commack (Consent and follow-up only)

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester (Consent and follow-up only)

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau (Consent only and Follow Up)

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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16-1285

Identifier Type: -

Identifier Source: org_study_id

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