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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 3

Conditions: Radical Cystectomy

Treatments: Procedure: Surgery Radical Cystectomy; Procedure: Ultrapro mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT02908061

16-1285

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

Surgery (Usual approach group)

Active Comparator group

Description:

standard surgery

Treatment:

Procedure: Surgery Radical Cystectomy

Surgery + Mesh Placement

Experimental group

Description:

prophylactic mesh at the time of standard surgery

Treatment:

Procedure: Ultrapro mesh

Procedure: Surgery Radical Cystectomy