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Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT00793728
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Amador Garci-a Ruiz de Gordejuela, Hospital Universitari de Bellvitge

Brief Summary:
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 or disease Intervention/treatment Phase
Morbid Obesity Procedure: Sleeve gastrectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy
Study Start Date : October 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Weight lose [ Time Frame: One year ]
  2. Food tolerance [ Time Frame: One year ]
  3. Quality of life [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Metabolic syndrome outcome [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Amador Garci-a Ruiz de Gordejuela, Hospital Universitari de Bellvitge:
Morbid obesity
High risk

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