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

Phase 3Active Not RecruitingNCT02908061

Memorial Sloan Kettering Cancer Center178 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

178

Conditions

Radical Cystectomy

Interventions

Surgery Radical CystectomyPROCEDURE

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

Ultrapro meshPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Basking Ridge, New Jersey, United States

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

Middletown, New Jersey, United States

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

Montvale, New Jersey, United States

Outcomes

Primary Outcomes

Number of patients with incidence of radiographic Parastomal Hernia

Time frame: within 2 years of RC and IC.

Data from ClinicalTrials.gov

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