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Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sleeve gastrectomy
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, High risk

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antrectomy

Without antrectomy

Arm Description

Outcomes

Primary Outcome Measures

Weight lose
Food tolerance
Quality of life

Secondary Outcome Measures

Metabolic syndrome outcome

Full Information

First Posted
November 18, 2008
Last Updated
August 19, 2015
Sponsor
Hospital Universitari de Bellvitge
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1. Study Identification

Unique Protocol Identification Number
NCT00793728
Brief Title
Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy
Official Title
Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Morbid obesity, High risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antrectomy
Arm Type
Active Comparator
Arm Title
Without antrectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Intervention Description
Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach
Primary Outcome Measure Information:
Title
Weight lose
Time Frame
One year
Title
Food tolerance
Time Frame
One year
Title
Quality of life
Time Frame
One year
Secondary Outcome Measure Information:
Title
Metabolic syndrome outcome
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amador Garcia Ruiz de Gordejuela, Consultant
Organizational Affiliation
Consultant of Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jordi Pujol Gebelli, Consultant
Organizational Affiliation
Consultant of Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carles Masdevall Noguera, Consultant
Organizational Affiliation
Consultant of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

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