Patient Enrollment Begins in Study on Efficacy of GORE SEAMGUARD(R) Staple Line Reinforcement for Circular Surgical Staplers.More Than 2,500 Colorectal Implants of GORE SEAMGUARD([R]) Bioabsorbable Staple Line Reinforcement for Circular Surgical Staplers in Past Year
FLAGSTAFF, Ariz. -- W. L. Gore & Associates (Gore) today announced that patient enrollment has begun in a study entitled, "Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses." The primary purpose of this prospective, randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. multicenter study is to evaluate and compare the outcomes of high risk colorectal or coloanal anastomoses constructed with GORE SEAMGUARD([R]) 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 a·nas·to·mo·sis
n. pl. a·nas·to·mo·ses
1. The connection of separate parts of a branching system to form a network, as of leaf veins, blood vessels, or a river and its branches.
2. leakage, anastomotic stricture stricture /stric·ture/ (strik´chur) stenosis.
A circumscribed narrowing of a hollow structure. and time to ileostomy ileostomy /il·e·os·to·my/ (il?e-os´tah-me) surgical creation of an opening into the ileum, with a stoma on the abdominal wall.
1. closure. The first synthetic, bioabsorbable material of its kind, GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is used widely in procedures where soft tissue anastomosis anastomosis /anas·to·mo·sis/ (ah-nas?tah-mo´sis) pl. anastomo´ses [Gr.]
1. communication between vessels by collateral channels.
2. with staple line reinforcement is needed and has been used in more than 2,500 colorectal procedures over the past year alone.
The Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses 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([R]) Material will be utilized and compared with the standard technique of no staple line reinforcement.
According to Anthony Senagore, MD, MS, MBA MBA
Master of Business Administration
Noun 1. MBA - a master's degree in business
Master in Business, Master in Business Administration at the Ferguson Clinic, Grand Rapids, MI and Principal Investigator for the Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses study, "Minimizing post-operative leaks and stricture associated with high risk anastomoses is a critical issue in low anterior resections. The design of the Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses study is such that we expect to get important data about the effectiveness of bioabsorbable staple line reinforcement material in anastomoses as compared to no reinforcement, as is often done today."
Morris E. Franklin, MD, FACS FACS Fellow of the American College of Surgeons.
Fellow of the American College of Surgeons
fluorescence-activated cell sorter. at the Texas Endosurgery Institute, and fellow Investigator for the Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses study, added, "While the bariatric surgery community well understands the benefits of GORE SEAMGUARD([R]) Material in reducing the incidence of perioperative perioperative /peri·op·er·a·tive/ (-op´er-ah-tiv) pertaining to the period extending from the time of hospitalization for surgery to the time of discharge.
adj. leaks and bleeding in a variety of open and minimally invasive surgeries, a clearer picture of its efficacy in low anterior resections will be welcomed."
"Gore continues to work closely with leading surgeons in colorectal surgery to further demonstrate the benefits of the GORE SEAMGUARD([R]) Material and address anastomotic integrity. This study will provide further insights into utilizing GORE SEAMGUARD([R]) 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," added Jason Smith, Product Specialist with Gore.
GORE SEAMGUARD([R]) Bioabsorbable Staple Line Reinforcement is thinner than other reinforcement materials and is completely absorbed within six months--eliminating the risk of erosion into adjacent tissue. The microporous biomaterial is composed of a glycolide (PGA (1) (Professional Graphics Adapter) An early IBM PC display standard for 3D processing with 640x480x256 resolution. It was not widely used.
(2) (Programmable Gate Array) See gate array and FPGA. ) and trimethylene carbonate (TMC TMC Technology Marketing Corporation (Norwalk, Connecticut)
TMC Texas Medical Center (Houston, TX)
TMC Traffic Message Channel
TMC The Movie Channel
TMC Traffic Management Center ) copolymer copolymer: see polymer. with an extensive history of safety in sutures, surgical meshes and implantable devices. Since the material is entirely synthetic, it does not carry the risk of animal-source contamination. This bioabsorbable membrane also has less risk of long-term complications associated with permanent materials, such as migration, erosion, calcification calcification /cal·ci·fi·ca·tion/ (kal?si-fi-ka´shun) the deposit of calcium salts in a tissue.
dystrophic calcification and providing a nidus nidus /ni·dus/ (ni´dus) pl. ni´di [L.]
1. the point of origin or focus of a morbid process.
2. nucleus (2). for infection.
ABOUT W. L. GORE & ASSOCIATES
Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical materials for hernia repair, soft tissue reconstruction, staple line reinforcement, and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 11th consecutive year. For more information, visit http://www.goremedical.com.
Products listed may not be available in all markets pending regulatory clearance. GORE, SEAMGUARD([R]), and design are trademarks of W. L. Gore & Associates.