Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

Bleeding on Lineal Stapled Anastomoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180140
• Other study ID #: Seamguard Study
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2010
• Last updated: August 10, 2010
• Start date: March 2006
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• circular anastomoses

• bariatric surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bleeding on Lineal Stapled Anastomoses
• Hemorrhage
• Leak on Lineal Stapled Anastomoses

Intervention

Device:
• Seamguard
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias	Unidad mixta de Investigación HUC-ULL, Universidad de La Laguna

Country where clinical trial is conducted

Spain,