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
1 other identifier
interventional
178
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2016
Longer than P75 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 9, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2026
CompletedMarch 30, 2026
March 1, 2026
9.7 years
September 9, 2016
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with incidence of radiographic Parastomal Hernia
within 2 years of RC and IC.
Study Arms (2)
Surgery (Usual approach group)
ACTIVE COMPARATORstandard surgery
Surgery + Mesh Placement
EXPERIMENTALprophylactic mesh at the time of standard surgery
Interventions
All surgeries will be performed in an open or laparoscopic fashion.
Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.
Eligibility Criteria
You may qualify if:
- Patients undergoing RC and IC formation in an elective setting,for cancer.
You may not qualify if:
- Expected survival \< 12 months
- Salvage RC
- Distant metastatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent and follow-up only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645, 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, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent only and Follow Up)
Uniondale, New York, 11553, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Bochner, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2016
First Posted
September 20, 2016
Study Start
August 1, 2016
Primary Completion
March 25, 2026
Study Completion
March 25, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03