Spots Global Cancer Trial Database for Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
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Trial Identification
Brief Title: Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
Official Title: Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
Study ID: NCT00663819
Study Description
Brief Summary: The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.
Detailed Description: This is a randomized prospective trial that compares the use of GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (CBSG) to standard stapling techniques in colorectal resections. The potential exists to utilize CBSG as a means of lowering the rate of post-operative anastomotic leakage and bleeding in high-risk colorectal, coloanal, and ileoanal anastomoses.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama, Mobile, Alabama, United States
University of Southern California, Keck School of Medicine, Los Angeles, California, United States
University of South Florida-Cleveland Clinic Florida, Weston, Florida, United States
Advocate Healthcare/Good Shepard Hospital, Barrington, Illinois, United States
John Stroger Hospital of Cook County, Chicago, Illinois, United States
Peoria Surgical Group, Peoria, Illinois, United States
Colon and Rectal Surgery-NEICRS Group, Fort Wayne, Indiana, United States
Kenderick Regional Center, Indianapolis, Indiana, United States
Spectrum Health -Ferguson Group, Grand Rapids, Michigan, United States
Duluth Clinic, Duluth, Minnesota, United States
Albany Medical College, Albany, New York, United States
St. Lukes-Roosevelt Hospital Center, New York, New York, United States
New York Presbyterian Hospital, New York, New York, United States
University Hospitals of Cleveland, Case Medical Center, Cleveland, Ohio, United States
Texas Endosurgery Institute, San Antonio, Texas, United States
University of Utah Health Sciences Center and Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Contact Details
Name: Anthony J Senagore, MD, MBA, MS
Affiliation: University of Southern California, Keck School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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