Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

study id #: NCT00663819

condition: Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis

status: Terminated

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.

intervention:
Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Procedure: Staple line without reinforcement

start date: April 2008

estimated completion: October 2012

last updated: April 17, 2018

phase of development: Not Available

size / enrollment: 258

study design:
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

study 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.

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 ] [ Designated as safety issue: No ]
  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. [ Time Frame: post operative ] [ Designated as safety issue: No ]
  
• Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses [ Time Frame: post operative ] [ Designated as safety issue: No ]
  
• Provide a Cost/Benefit Analysis With Regard to the Use of CBSG in Stapled Circular Anastomoses [ Time Frame: study completion ] [ Designated as safety issue: No ]
  
• Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses. [ Time Frame: study completion ] [ Designated as safety issue: No ]

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).

sponsor: W.L.Gore & Associates

investigators: Anthony J Senagore, MD, MBA, MS

locations: United States