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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
colorectal and coloanal anastomotic staple line without reinforcement
University of South Alabama
Mobile, Alabama, United States
University of Southern California, Keck School of Medicine
Los Angeles, California, United States
University of South Florida-Cleveland Clinic Florida
Weston, Florida, United States
Advocate Healthcare/Good Shepard Hospital
Barrington, Illinois, United States
John Stroger Hospital of Cook County
Chicago, Illinois, United States
Peoria Surgical Group
Peoria, Illinois, United States
Colon and Rectal Surgery-NEICRS Group
Fort Wayne, Indiana, United States
Kenderick Regional Center
Indianapolis, Indiana, United States
Spectrum Health -Ferguson Group
Grand Rapids, Michigan, United States
Duluth Clinic
Duluth, Minnesota, United States
...and 6 more locations
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
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.
Time frame: Completion of procedure through 4-12 weeks post procedure
Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
Time frame: Post operative
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
Time frame: 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.
Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.
Time frame: Within 4 - 12 weeks post-surgery
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