Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|