Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

W.L. Gore & Associates

Status

Terminated

Conditions

Familial Adenomatous Polyposis

Ulcerative Colitis

Diverticulitis

Rectal Cancer

Treatments

Procedure: Staple line without reinforcement

Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement

Study type

Interventional

Funder types

Industry

Identifiers

NCT00663819

CS150 (Other Identifier)

2008-109

Details and patient eligibility

About

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.

Full description

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.

Enrollment

258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).