Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes

January 17, 2020 updated by: James Tankel, Shaare Zedek Medical Center

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

A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.

Study Overview

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

Observational

Enrollment (Actual)

156

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

      • Jerusalem, Israel
        • Shaare Zedek Medical Center

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing laparoscopic sleeve gastrectomy at a single center between April and October 2012

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

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
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.
A correlation between % total weight loss 4 weeks following surgery and % total weight loss at 7 years follow up based on clinic measurements.
A comparison made between 4 weeks and 7 years following the index surgery.

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.
A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this 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)

April 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

November 30, 2019

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

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.

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