Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
NCT ID: NCT00663819
Last Updated: 2018-04-17
Study Results
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View full resultsBasic Information
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TERMINATED
NA
258 participants
INTERVENTIONAL
2008-04-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Device
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
Procedure/Surgery
Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Staple line without reinforcement
colorectal and coloanal anastomotic staple line without reinforcement
Interventions
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GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
Staple line without reinforcement
colorectal and coloanal anastomotic staple line without reinforcement
Eligibility Criteria
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Inclusion Criteria
, diverticulitis, perforation of the bowel/trauma.
* Subjects undergoing Hartmann's reversal with restorative proctectomy (\<10 cm from the anal verge).
* Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery.
* Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer.
Exclusion Criteria
* Subjects who have significant intraoperative hypotension or cardiac events.
* Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values).
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Anthony J Senagore, MD, MBA, MS
Role: PRINCIPAL_INVESTIGATOR
University of Southern California, Keck School of Medicine
Locations
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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
Countries
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Other Identifiers
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CS150
Identifier Type: OTHER
Identifier Source: secondary_id
2008-109
Identifier Type: -
Identifier Source: org_study_id
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