Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Not Applicable

Terminated

Conditions: Rectal Cancer
Diverticulitis
Familial Adenomatous Polyposis
Ulcerative Colitis

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

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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Device	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
Procedure/Surgery	Staple line without reinforcement	Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak	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 Outcome Measures

Name	Time	Method
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	Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.

Locations (16): John Stroger Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
New York Presbyterian Hospital
🇺🇸
New York, New York, United States
St. Lukes-Roosevelt Hospital Center
🇺🇸
New York, New York, United States
University Hospitals of Cleveland, Case Medical Center
🇺🇸
Cleveland, Ohio, United States
University of South Florida-Cleveland Clinic Florida
🇺🇸
Weston, Florida, United States
University of Utah Health Sciences Center and Huntsman Cancer Hospital
🇺🇸
Salt Lake City, Utah, United States
University of Southern California, Keck School of Medicine
🇺🇸
Los Angeles, California, United States
Colon and Rectal Surgery-NEICRS Group
🇺🇸
Fort Wayne, Indiana, United States
Advocate Healthcare/Good Shepard Hospital
🇺🇸
Barrington, Illinois, United States
Spectrum Health -Ferguson Group
🇺🇸
Grand Rapids, Michigan, United States
University of South Alabama
🇺🇸
Mobile, Alabama, United States
Peoria Surgical Group
🇺🇸
Peoria, Illinois, United States
Kenderick Regional Center
🇺🇸
Indianapolis, Indiana, United States
Texas Endosurgery Institute
🇺🇸
San Antonio, Texas, United States
Duluth Clinic
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Duluth, Minnesota, United States
Albany Medical College
🇺🇸
Albany, New York, United States