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

Phase 3

Active, not recruiting

• Conditions: Radical Cystectomy
• Interventions: Procedure: Surgery Radical Cystectomy; Procedure: Ultrapro mesh

• Registration Number: NCT02908061
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

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

Read More

Exclusion Criteria

• Expected survival < 12 months
• Salvage RC
• Distant metastatic disease

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery + Mesh Placement	Ultrapro mesh	prophylactic mesh at the time of standard surgery
Surgery (Usual approach group)	Surgery Radical Cystectomy	standard surgery
Surgery + Mesh Placement	Surgery Radical Cystectomy	prophylactic mesh at the time of standard surgery

Primary Outcome Measures

Name	Time	Method
Number of patients with incidence of radiographic Parastomal Hernia	within 2 years of RC and IC.

Trial Locations

Locations (7)

Memorial Sloan Kettering Commack (Consent and follow-up only); 🇺🇸 Commack, New York, United States

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

Memorial Sloan Kettering Westchester (Consent and follow-up only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Consent only and Follow Up); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Bergen (Consent and follow-up only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and follow-up only); 🇺🇸 Middletown, New Jersey, United States