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Clinical Trials/NCT02908061
NCT02908061
Active, not recruiting
Phase 3

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

Memorial Sloan Kettering Cancer Center7 sites in 1 country178 target enrollmentAugust 1, 2016
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ConditionsRadical Cystectomy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Radical Cystectomy
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
178
Locations
7
Primary Endpoint
Number of patients with incidence of radiographic Parastomal Hernia
Status
Active, not recruiting
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
August 1, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of patients with incidence of radiographic Parastomal Hernia

Time Frame: within 2 years of RC and IC.

Study Sites (7)

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