Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

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

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.

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.

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).