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.

Completed

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Key information

Conditions

Leak on Lineal Stapled Anastomoses Bleeding on Lineal Stapled Anastomoses Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example)

Exclusion criteria

circular anastomoses
bariatric surgery

Treatment and study plan

Seamguard

Device

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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Collaborators

Unidad mixta de Investigación HUC-ULL
University of La Laguna

Registry information

Official study title

Use of Seamguard to Prevent Digestive Leak and Bleeding on Lineal Stapled Anastomoses: a Prospective Randomized Clinical Trial

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2010
First posted: Aug 11, 2010
Registry last updated: Aug 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed