Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amador Garci-a Ruiz de Gordejuela, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT00793728
First received: November 18, 2008
Last updated: August 19, 2015
Last verified: August 2015
  Purpose

This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.


Condition Intervention
Morbid Obesity
Procedure: Sleeve gastrectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Weight lose [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Food tolerance [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic syndrome outcome [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2008
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antrectomy Procedure: Sleeve gastrectomy
Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach
Active Comparator: Without antrectomy Procedure: Sleeve gastrectomy
Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI>40 kg/m2
  • Age >18 years old
  • Eligible for laparoscopic surgery

Exclusion Criteria:

  • Prior bariatric surgery
  • Sleeve gastrectomy as a part of a duodenal switch
  • Second time surgery before 18 months
  • Other procedures done during the surgery
  • Conversion to laparotomy
  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: NCT00793728

Locations
Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Amador Garcia Ruiz de Gordejuela, Consultant Consultant of Surgery
Principal Investigator: Jordi Pujol Gebelli, Consultant Consultant of Surgery
Principal Investigator: Carles Masdevall Noguera, Consultant Consultant of Surgery
  More Information

No publications provided

Responsible Party: Amador Garci-a Ruiz de Gordejuela, MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT00793728     History of Changes
Other Study ID Numbers: PR131/08
Study First Received: November 18, 2008
Last Updated: August 19, 2015
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitari de Bellvitge:
Morbid obesity
High risk

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

ClinicalTrials.gov processed this record on August 31, 2015