Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- W.L.Gore & Associates
- Enrollment
- 258
- Locations
- 16
- Primary Endpoint
- Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility 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).
Outcomes
Primary Outcomes
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
Time Frame: Completion of procedure through 4-12 weeks post procedure
The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.
Secondary Outcomes
- Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.(Post operative)
- Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses(Post operative)
- Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.(Within 4 - 12 weeks post-surgery)