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Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses


Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study




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.

Study Status: Terminated


Condition Intervention Phase
Ileostomy, When Applicable
Rectal Cancer, When Applicable
Ulcerative Colitis, FAP, Diverticulitis, Hartmann`s Reversal
Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
Procedure: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Verified by W.L.Gore & Associates April, 2013

Sponsored by: W.L.Gore & Associates
Information provided by: W.L.Gore & Associates identifier: NCT00663819

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

University of South Florida-Cleveland Clinic Florida
Weston, Florida 33331
United States

Anthony J Senagore, MD, MBA, MS., Principal Investigator

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