Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

Hospital Universitario de Canarias

Status and phase: Completed; Phase 4

Conditions: Leak on Lineal Stapled Anastomoses; Bleeding on Lineal Stapled Anastomoses

Treatments: Device: Seamguard

Study type: Interventional

Funder types: Other

Identifiers

NCT01180140

Seamguard Study

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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113 participants in 2 patient groups

1

No Intervention group

Description:

without seamguard

2

Experimental group

Description:

with seamguard

Treatment:

Device: Seamguard