Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Stopped early · Not applicable

Conditions studied: Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis

In brief

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.

Key facts

Study ID

NCT00663819

Run by

W.L.Gore & Associates

People needed

258

Starts

2008-04-01

Expected to finish

2012-10-01

Last updated by the study team

2018-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who will undergo restorative proctectomy or proctocolectomy (<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis
• , 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.

You may not qualify if…

• Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease.
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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