Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy
August 19, 2015 updated by: Amador Garci-a Ruiz de Gordejuela, Hospital Universitari de Bellvitge
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
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
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
-
-
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 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Antrectomy
|
Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach
|
|
ACTIVE_COMPARATOR: Without antrectomy
|
Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: One year
|
One year
|
|
Weight lose
Time Frame: One year
|
One year
|
|
Food tolerance
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Metabolic syndrome outcome
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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
October 1, 2008
Primary Completion (ACTUAL)
August 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
November 18, 2008
First Submitted That Met QC Criteria
November 18, 2008
First Posted (ESTIMATE)
November 19, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 20, 2015
Last Update Submitted That Met QC Criteria
August 19, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR131/08
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.