- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02733562
Results of Sleeve Gastrectomy Surgery in Relation With Eating Habits (After One Year) (Behavior)
April 10, 2016 updated by: Sergio Gabriel Susmallian, Assuta Medical Center
The Effect of Different Eating Habits on Weight Loss in the First Year After Sleeve Gastrectomy
Sleeve gastrectomy is one of the most common surgical procedures performed today for patients that undergo bariatric surgery.
One of the primary reasons for morbid obesity is unhealthy eating habits and the belief that changes in those habits can ensure the success.
Objectives: The investigators aimed to explore the effect of different eating habits prior to the bariatric surgery on the surgery success and on different aspect of quality of life.
Design: The investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation.
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation.
The investigators divided the patients into groups according to their pre-operation eating habits: binge, sweet, snack and high volume and compared different aspects of the surgery such as weight loss, BMI and distance from ideal weight.
The investigators also examined the effect of the surgery on the quality of life, sexual life, physical activity, eating habits and satisfaction from the surgery by a telephonic survey that was conducted up to one year after the surgery.
Study Type
Observational
Enrollment (Actual)
300
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients underwent sleeve gastrectomy
Description
Inclusion Criteria:
- morbid obesity
- approved for bariatric surgery by the hospital's committee
- Patients that underwent primary surgery
Exclusion Criteria:
- recurrent surgery
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Binge eaters
Classificated preoperatively
|
|
Volume eaters
Classificated preoperatively
|
|
sweet eaters
Classificated preoperatively
|
|
snack eaters
Classificated preoperatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight loss
Time Frame: one year
|
measured in KG
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
March 26, 2016
First Submitted That Met QC Criteria
April 8, 2016
First Posted (Estimate)
April 11, 2016
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
April 10, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- AMC 0216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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