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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospital Universitario Virgen de la Arrixaca
Sponsor:
Information provided by (Responsible Party):
Israel Abellan Morcillo, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT02077517
First received: February 24, 2014
Last updated: March 2, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Morbid Obesity
Procedure: Roux en Y Gastric Bypass
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Virgen de la Arrixaca:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: within the first month after surgery ] [ Designated as safety issue: Yes ]
    To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis


Secondary Outcome Measures:
  • hospital stay [ Time Frame: within the first month after surgery ] [ Designated as safety issue: Yes ]
  • % of excess weight lost [ Time Frame: five years after surgery ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • operative time [ Time Frame: during surgical procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: January 2007
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: hand sewn anastomosis
Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing
Procedure: Roux en Y Gastric Bypass
Active Comparator: stapled anastomosis
Patients with stapled anastomosis during Roux en Y Gastric Bypass performing
Procedure: Roux en Y Gastric Bypass

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients over 18 years
  • absence of previous bariatric surgery

Exclusion Criteria:

  • less than 18 years old
  • coagulation disorders or liver cirrhosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02077517

Locations
Spain
Hospital Clinico Universitario Virgen de la Arrixaca Recruiting
El Palmar, Murcia, Spain
Contact: Israel Abellan, Ph    615217706      
Sub-Investigator: Israel Abellan, Ph         
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
  More Information

No publications provided

Responsible Party: Israel Abellan Morcillo, Bariatric Surgery unit, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT02077517     History of Changes
Other Study ID Numbers: OBES-001
Study First Received: February 24, 2014
Last Updated: March 2, 2014
Health Authority: Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad

Keywords provided by Hospital Universitario Virgen de la Arrixaca:
Roux en Y Gastric Bypass
Postoperative complications
Hand sewn anastomosis
Stapled anastomosis

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014