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NCT02908061 Clinical Trial

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

Radical Cystectomy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02908061
Other study ID # 16-1285
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 2016
Est. completion date August 2024

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 178
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgery Radical Cystectomy
All surgeries will be performed in an open or laparoscopic fashion.
• Ultrapro mesh
Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Consent and follow-up only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent and follow-up only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent and follow-up only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent and follow-up only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (Consent only and Follow Up) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with incidence of radiographic Parastomal Hernia within 2 years of RC and IC.
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