NCT00663819

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Ulcerative Colitis
• Familial Adenomatous Polyposis
• Diverticulitis

Interventions

Type	Name	Description
DEVICE	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	Staple line without reinforcement	colorectal and coloanal anastomotic staple line without reinforcement

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-04-22
• Last updated: 2018-04-17
• Results posted: 2014-09-10

Locations

16 sites across 1 country: United States