Expired Study
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Peoria, Illinois 61606


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 summary:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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).


NCT ID:

NCT00663819


Primary Contact:

Principal Investigator
Anthony J Senagore, MD, MBA, MS
University of Southern California, Keck School of Medicine


Backup Contact:

N/A


Location Contact:

Peoria, Illinois 61606
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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