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

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ClinicalTrials.gov Identifier: NCT02077517
Recruitment Status : Unknown
Verified March 2014 by Israel Abellan Morcillo, Hospital Universitario Virgen de la Arrixaca.
Recruitment status was:  Recruiting
First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Roux en Y Gastric Bypass Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
Study Start Date : January 2007
Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. postoperative complications [ Time Frame: within the first month after surgery ]
    To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis


Secondary Outcome Measures :
  1. hospital stay [ Time Frame: within the first month after surgery ]
  2. % of excess weight lost [ Time Frame: five years after surgery ]

Other Outcome Measures:
  1. operative time [ Time Frame: during surgical procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by Israel Abellan Morcillo, 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