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Brief Title: Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia

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

INTRODUCTION

  • Org Study ID: 16-1285
  • Secondary ID: N/A
  • NTC ID: NCT02908061
  • Sponsor: Memorial Sloan Kettering Cancer Center

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.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of patients with incidence of radiographic Parastomal Hernia

Primary Outcome 1 - Timeframe: within 2 years of RC and IC.

CONDITION

  • Radical Cystectomy

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bernard Bochner, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Bernard Bochner, MD

Phone: 646-422-4387

Email: N/A

LOCATION

Facility Status Contact
Facility: Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact:
Bernard Bochner, MD
646-422-4387
Facility: Memorial Sloan Kettering Monmouth (Consent and follow-up only)
Middletown, New Jersey 07748
United States
Status: Recruiting Contact:
Bernard Bochner, MD
646-422-4387
Facility: Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey 07645
United States
Status: Recruiting Contact:
Bernard Bochner, MD
646-422-4387
Facility: Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York
United States
Status: Recruiting Contact:
Bernard Bochner, PhD
646-422-4387
Facility: Memorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison, New York 10604
United States
Status: Recruiting Contact:
Bernard Bochner, MD
646-422-4387
Facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Status: Recruiting Contact:
Bernard Bochner, MD
646-422-4387
Facility: Memorial Sloan Kettering Nassau (Consent only and Follow Up)
Uniondale, New York 11553
United States
Status: Recruiting Contact:
Bernard Bochner, MD
646-422-4387