Gore initiates enrollment in Seamguard surgical staplers efficacy study

The primary purpose of this prospective, randomized multicenter study is to evaluate and compare the outcomes of high risk colorectal or coloanal anastomoses constructed with Gore Seamguard Bioabsorbable Staple Line Reinforcement for circular surgical staplers to standard non-reinforced colorectal and coloanal techniques with respect to the incidence of post-operative anastomotic leakage, anastomotic stricture and time to ileostomy closure.

The study will include approximately 750 patients undergoing low anterior resection at twelve to fourteen centers throughout the US and Europe. The patients will be followed through ileostomy closure and will be evaluated for post-operative complications, including anastomotic leaks or strictures. The Gore Seamguard Material will be utilized and compared with the standard technique of no staple line reinforcement.

The first synthetic, bioabsorbable material of its kind, Gore Seamguard Bioabsorbable Staple Line Reinforcement is said to be used widely in procedures where soft tissue anastomosis with staple line reinforcement is needed.

Jason Smith, product specialist with Gore, said: “This study will provide further insights into utilizing Gore Seamguard Bioabsorbable Staple Line Reinforcement as a means of lowering the rate of post-operative anastomotic leakage and stenosis in high-risk stapled colorectal and coloanal anastomoses.”