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
Verified date | April 2024 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
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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