Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
The purpose of this study is to determinate the utility of staple-line reinforcement on lineal gastrointestinal anastomoses.
Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive lineal stapled anastomoses.
Leak on Lineal Stapled Anastomoses
Bleeding on Lineal Stapled Anastomoses
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial|
|Study Start Date:||March 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
No Intervention: 1
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180140
|Hospital Universitario de Canarias|
|La Laguna, Santa Cruz de Tenerife, Spain, 38320|