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

Primary Purpose

Radical Cystectomy

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Surgery Radical Cystectomy
Ultrapro mesh
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radical Cystectomy focused on measuring Mesh Placement, Radical Cystectomy, 16-1285

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
  • Memorial Sloan Kettering Monmouth (Consent and follow-up only)
  • Memorial Sloan Kettering Bergen (Consent and follow-up only)
  • Memorial Sloan Kettering Commack (Consent and follow-up only)
  • Memorial Sloan Kettering Westchester (Consent and follow-up only)
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  • Memorial Sloan Kettering Nassau (Consent only and Follow Up)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery (Usual approach group)

Surgery + Mesh Placement

Arm Description

standard surgery

prophylactic mesh at the time of standard surgery

Outcomes

Primary Outcome Measures

Number of patients with incidence of radiographic Parastomal Hernia

Secondary Outcome Measures

Full Information

First Posted
September 9, 2016
Last Updated
April 24, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02908061
Brief Title
A Study to Determine if Mesh Placement During Bladder Surgery Can Reduce the Chances of Developing a Hernia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radical Cystectomy
Keywords
Mesh Placement, Radical Cystectomy, 16-1285

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery (Usual approach group)
Arm Type
Active Comparator
Arm Description
standard surgery
Arm Title
Surgery + Mesh Placement
Arm Type
Experimental
Arm Description
prophylactic mesh at the time of standard surgery
Intervention Type
Procedure
Intervention Name(s)
Surgery Radical Cystectomy
Intervention Description
All surgeries will be performed in an open or laparoscopic fashion.
Intervention Type
Procedure
Intervention Name(s)
Ultrapro mesh
Intervention Description
Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.
Primary Outcome Measure Information:
Title
Number of patients with incidence of radiographic Parastomal Hernia
Time Frame
within 2 years of RC and IC.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Bochner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Consent and follow-up only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent and follow-up only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent and follow-up only)
City
Commack
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Consent and follow-up only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent only and Follow Up)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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