Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
|ClinicalTrials.gov Identifier: NCT01180140|
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Leak on Lineal Stapled Anastomoses Bleeding on Lineal Stapled Anastomoses||Device: Seamguard||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||June 2010|
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 (NCT number): NCT01180140
|Hospital Universitario de Canarias|
|La Laguna, Santa Cruz de Tenerife, Spain, 38320|