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Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

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
N/A

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

Sponsored by: W.L.Gore & Associates
Information provided by: W.L.Gore & Associates
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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