- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235829
Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes
Predicting Weight Loss and Comorbid Improvement Early Post-operative Weight Loss Fails to Predict Outcomes 7 Years Following Laparoscopic Sleeve Gastrectomy: Does Early Weight Loss Matter
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients who underwent laparoscopic sleeve gastrectomy in the 6 month period between 01/04/2012 and 01/10/2019 were identified. For those meeting the inclusion criteria, demographic and medical data was extracted from hospital notes. This included initial BMI and the presence of, or treatment for, diabetes or hypertension.
Using the contact details available in the medical records, a scripted telephone interview was performed. The current weight of the patient as well as a current medical and drug history were elicited. This data was compared with data attained during initial patient interaction with the service.
Early weight loss, defined as weight lost in the 4 weeks following surgery, was subsequently correlated with outcomes in terms of weight loss and improvement/resolution of either hypertension or diabetes at a 7 year follow up interval.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Jerusalem, Israel
- Shaare Zedek Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity
- Have not undergone any further bariatric surgical procedures since the index operation
- Still be alive at the time of the study
- Have correct be contactable with the contact details present available in the electronic database
Exclusion Criteria:
- Missing data
- Uncontactable
- Unwilling to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between early % total weight loss and % total weight loss 7 years following surgery.
Time Frame: A comparison made between 4 weeks and 7 years following the index surgery.
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A correlation between % total weight loss 4 weeks following surgery and % total weight loss at 7 years follow up based on clinic measurements.
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A comparison made between 4 weeks and 7 years following the index surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..
Time Frame: A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.
|
Reduction / resolution of either hypertension or type 2 diabetes mellitus as defined by a reduction or cessation of medical treatment for the respective comorbidity.
Patient diagnoses before surgery were compared with medical and medication histories taken at 7 years follow up.
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A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SZMC-95/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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