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

NCT04235829 | Completed

• 1 other identifier: SZMC-95/19
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Diabetes Mellitus, Type 2; Gastrostomy; Morbid Obesity; Weight Loss

Keywords

sleeve gastrectomy; morbid obesity; predicting outcomes; early weight loss; hypertension; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Correlation between early % total weight loss and % total weight loss 7 years following 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 Outcomes (1)

• Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..

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

Interventions

Laparoscopic sleeve gastrectomy PROCEDURE

Form of obesity surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Missing data
• Uncontactable
• Unwilling to participate

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Obesity, Morbid; Weight Loss; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in General Surgery

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: January 22, 2020
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)