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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02908061

Enrollment

178

Registered

2016-09-20

Start date

2016-08-01

Completion date

2026-03-25

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radical Cystectomy

Keywords

Mesh Placement, Radical Cystectomy, 16-1285

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.

Interventions

PROCEDURESurgery Radical Cystectomy

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

PROCEDUREUltrapro mesh

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBernard Bochner, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026