Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

Phase 4

Completed

• Conditions: Leak on Lineal Stapled Anastomoses; Bleeding on Lineal Stapled Anastomoses
• Interventions: Device: Seamguard

• Registration Number: NCT01180140
• Lead Sponsor: Hospital Universitario de Canarias

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2009-08
• Study Completion: 2010-06
• Study First Submitted: 2010-07-18
• Status Verified: 2010-08
• Study First Submitted QC: 2010-08-10
• Last Update Submitted: 2010-08-10
• Study First Posted: 2010-08-11
• Last Update Posted: 2010-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Seamguard	with seamguard

Trial Locations

Locations (1)

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Santa Cruz de Tenerife, Spain