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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


  • Org Study ID: 16-1285
  • Secondary ID:
  • NCT ID: NCT02908061
  • NCT Alias:
  • Sponsor: Memorial Sloan Kettering Cancer Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: August 2016 Phase 3 Interventional

Primary Outcomes:

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

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

Condition:

  • Radical Cystectomy

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

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:

Link: Memorial Sloan Kettering Cancer Center

Locations

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