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Cola

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers

Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement

colorectal and coloanal anastomotic staple line without reinforcement

Staple line without reinforcement

Anthony J Senagore, MD, MBA, MS

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.

Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study

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.

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

W.L.Gore & Associates

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement

Procedure/Surgery

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Patients were considered for the study if they were at least 18 years of age and scheduled to undergo one the following (with the anastomosis \< 10 cm from the anal verge): low anterior resection, proctectomy, proctocolectomy or a restorative anastomosis by means of Hartmann's reversal, coloanal anastomosis, or ileo-pouch-anal anastomosis.

Dr. Anthony Senagore

Device

Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak

Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.

Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses

"Significant" Post Operative Complications

Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.

Overall Study

Spots Global Cancer Trial Database for staple line without reinforcement