Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity
May 6, 2019 updated by: Paolo Gentileschi, University of Rome Tor Vergata
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity.
Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
92
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 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
final group from which data have been considered 92 patients (47females and 45 males)
Description
Inclusion Criteria:
- BMI over 60 kg/m2 in high-risk patients,
- BMI between 50 and 60 kg/m2 in nondiabetic patients,
- BMI between 40 and 50 kg/m2 in patients refusing a complex procedure like Roux-en-Y gastric bypass,
- patients with severe gastric inflammatory disease and H. pylori infection,
- patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding
Exclusion Criteria:
- severe and documented gastroesophageal reflux disease
- previous gastric 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
resected gastric volume in laparoscopic sleeve gastrectomy
Time Frame: 5 years
|
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity
|
5 years
|
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 (ACTUAL)
January 1, 2013
Primary Completion (ACTUAL)
January 1, 2017
Study Completion (ACTUAL)
April 30, 2019
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
May 3, 2019
First Posted (ACTUAL)
May 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 7, 2019
Last Update Submitted That Met QC Criteria
May 6, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gastric Volume Sleeve
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.