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NCT02077517 Clinical Trial

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

Morbid Obesity Clinical Trial

— STAVHAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02077517
Other study ID # OBES-001
Secondary ID
Status Recruiting
Phase Phase 3
First received February 24, 2014
Last updated March 2, 2014
Start date January 2007

Study information
Verified date March 2014
Source Hospital Universitario Virgen de la Arrixaca
Contact n/a
Is FDA regulated No
Health authority Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Roux en Y Gastric Bypass

Locations
Country Name City State
Spain Hospital Clinico Universitario Virgen de la Arrixaca El Palmar Murcia

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Other operative time during surgical procedure Yes
Primary postoperative complications To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis within the first month after surgery Yes
Secondary hospital stay within the first month after surgery Yes
Secondary % of excess weight lost five years after surgery Yes
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