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

March 2, 2014 updated by: Israel Abellan Morcillo, Hospital Universitario Virgen de la Arrixaca
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • El Palmar, Murcia, Spain
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Arrixaca
        • Contact:
          • Israel Abellan, Ph
          • Phone Number: 615217706
        • Sub-Investigator:
          • Israel Abellan, Ph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients over 18 years
  • absence of previous bariatric surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: within the first month after surgery
To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis
within the first month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
hospital stay
Time Frame: within the first month after surgery
within the first month after surgery
% of excess weight lost
Time Frame: five years after surgery
five years after surgery

Other Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: during surgical procedure
during surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

March 2, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 2, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBES-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Morbid Obesity

Clinical Trials on Roux en Y Gastric Bypass

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe