Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180140

Enrollment

113

Registered

2010-08-11

Start date

2006-03-31

Completion date

2010-06-30

Last updated

2010-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding on Lineal Stapled Anastomoses, Leak on Lineal Stapled Anastomoses

Keywords

Seamguard, staple-line reinforcement, leak, bleeding

Brief 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.

Interventions

DEVICESeamguard

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* circular anastomoses * bariatric surgery

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026