Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial

Phase 3

• Conditions: Morbid Obesity
• Interventions: Procedure: Roux en Y Gastric Bypass

• Registration Number: NCT02077517
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

Brief Summary

The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2014-01
• Study First Submitted: 2014-02-24
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-02
• Last Update Submitted: 2014-03-02
• Study First Posted: 2014-03-04
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• patients over 18 years
• absence of previous bariatric surgery

Exclusion Criteria

• less than 18 years old
• coagulation disorders or liver cirrhosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hand sewn anastomosis	Roux en Y Gastric Bypass	Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing
stapled anastomosis	Roux en Y Gastric Bypass	Patients with stapled anastomosis during Roux en Y Gastric Bypass performing

Primary Outcome Measures

Name	Time	Method
postoperative complications	within the first month after surgery	To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis

Secondary Outcome Measures

Name	Time	Method
hospital stay	within the first month after surgery
% of excess weight lost	five years after surgery

Trial Locations

Locations (1)

Hospital Clinico Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain