Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02908061
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Radical Cystectomy Procedure: Surgery Radical Cystectomy Procedure: Ultrapro mesh Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : August 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Surgery (Usual approach group)
standard surgery
Procedure: Surgery Radical Cystectomy
All surgeries will be performed in an open or laparoscopic fashion.

Experimental: Surgery + Mesh Placement
prophylactic mesh at the time of standard surgery
Procedure: Surgery Radical Cystectomy
All surgeries will be performed in an open or laparoscopic fashion.

Procedure: Ultrapro mesh
Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.




Primary Outcome Measures :
  1. Number of patients with incidence of radiographic Parastomal Hernia [ Time Frame: within 2 years of RC and IC. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908061


Contacts
Layout table for location contacts
Contact: Bernard Bochner, MD 646-422-4387
Contact: Guido Dalbagni, MD 646-422-4394

Locations
Layout table for location information
United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Bernard Bochner, MD    646-422-4387      
Memorial Sloan Kettering Monmouth (Consent and follow-up only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Bernard Bochner, MD    646-422-4387      
Memorial Sloan Kettering Bergen (Consent and follow-up only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Bernard Bochner, MD    646-422-4387      
United States, New York
Memorial Sloan Kettering Commack (Consent and follow-up only) Recruiting
Commack, New York, United States
Contact: Bernard Bochner, PhD    646-422-4387      
Memorial Sloan Kettering Westchester (Consent and follow-up only) Recruiting
Harrison, New York, United States, 10604
Contact: Bernard Bochner, MD    646-422-4387      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Bernard Bochner, MD    646-422-4387      
Contact: Guido Dalbagni, MD    646-422-4394      
Principal Investigator: Bernard Bochner, MD         
Memorial Sloan Kettering Nassau (Consent only and Follow Up) Recruiting
Uniondale, New York, United States, 11553
Contact: Bernard Bochner, MD    646-422-4387      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Bernard Bochner, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02908061    
Other Study ID Numbers: 16-1285
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Mesh Placement
Radical Cystectomy
16-1285
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Pathological Conditions, Anatomical