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Mesh Placement for Hernia Prevention After Bladder Surgery

Phase 3

Waitlist Available

Led By Bernard Bochner, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 years of rc and ic.

Awards & highlights

Study Summary

This trial is testing whether a mesh added to bladder removal surgery has any benefits or drawbacks compared to the surgery without the mesh.

Who is the study for?

This trial is for patients who are having bladder removal surgery (Radical Cystectomy) due to cancer, without distant spread of the disease and with an expected survival of more than a year. It's not suitable for those undergoing salvage cystectomy.Check my eligibility

What is being tested?

The study is testing if using Ultrapro mesh during bladder removal surgery can lower the risk of developing a hernia compared to just the standard surgery without mesh.See study design

What are the potential side effects?

Potential side effects may include discomfort or pain at the surgical site, infection risks, possible allergic reactions to the mesh material, and complications related to hernia formation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for bladder removal and urinary diversion surgery for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 years of rc and ic.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 years of rc and ic.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 years of rc and ic. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with incidence of radiographic Parastomal Hernia

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Surgery + Mesh PlacementExperimental Treatment2 Interventions

prophylactic mesh at the time of standard surgery

Group II: Surgery (Usual approach group)Active Control1 Intervention

standard surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrapro mesh

2011

N/A

~150

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,444 Total Patients Enrolled

Bernard Bochner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

601 Total Patients Enrolled

Media Library

Radical Cystectomy Clinical Trial Eligibility Overview. Trial Name: NCT02908061 — Phase 3

Radical Cystectomy Research Study Groups: Surgery (Usual approach group), Surgery + Mesh Placement

Radical Cystectomy Clinical Trial 2023: Radical Cystectomy Highlights & Side Effects. Trial Name: NCT02908061 — Phase 3

Radical Cystectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02908061 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still spots available for participants in this research project?

"As can be seen on clinicaltrials.gov, this trial is not presently looking for patients as recruitment has concluded. The trial was initially posted on 8/1/2016 but the most recent edit was on 4/22/2022. There are, however, 174 other trials that are actively recruiting patients."

Answered by AI

Could you provide a number for how many hospitals are part of this research?

"7 different hospitals are currently enrolling patients for this study. The trial locations are situated in Uniondale, Montvale, and Basking Ridge as well as other close by towns. If you enroll, it is best to choose the location nearest to your home to cut down on travel."

Answered by AI

Could you please tell us the Ultrapro mesh's safety profile?

"This medical device has received a 3 for safety from our team at Power. This is because it is a Phase 3 trial, meaning that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "A Study to Determine if Mesh Placement During Bladder Surgery Can Reduce the Chances of Developing a Hernia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02908061.

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