Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

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).