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
NCT ID: NCT02908061
Sponsor: Memorial Sloan Kettering Cancer Center

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

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

Radical Cystectomy

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

Name: Bernard Bochner, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Name: Bernard Bochner, MD

Phone: 646-422-4387

Email: N/A

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

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

BRIEF SUMMARY

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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