Effect of Sarcopenic Obesity on Weight Loss Outcomes and Quality of Life After Laparoscopic Sleeve Gastrectomy

Completed

• Conditions: Sarcopenic Obesity; Body Composition
• Interventions: Procedure: Laparoscopic sleeve gastrectomy

• Registration Number: NCT05826210
• Lead Sponsor: Fujian Medical University

Brief Summary

The purpose of this study is to assess the impact of sarcopenic obesity (SO) on weight loss outcomes and improvement of quality of life after laparoscopic sleeve gastrectomy.

Detailed Description

Sarcopenic obesity is a state in which a lack of muscle mass and strength coexists with an increase in fat mass, and it may affect the health outcome of people with obesity after laparoscopic sleeve gastrectomy (LSG).No studies have reported differences in weight loss outcomes between patients with SO and those with non-sarcopenic obesity (NSO) after LSG. Therefore, this study aimed to systematically evaluate the differences in weight loss and quality of life (QOL) evaluation between patients with SO and NSO after LSG and provide high-level evidence-based medical evidence for the impact of SO on weight loss in the obese population and refinement of follow-up strategies.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Obese patients who met the indications for LSG and were followed up regularly as planned after surgery.

Exclusion Criteria

1. incomplete critical clinical data;
2. incomplete imaging data;
3. insufficient follow-up data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sarcopenic obesity group	Laparoscopic sleeve gastrectomy	Patients who underwent LSG with FM/FFM\>0.80 calculated from the cross-sectional CT image of L3 vertebra.
Non-sarcopenic obesity group	Laparoscopic sleeve gastrectomy	Patients who underwent LSG with FM/FFM\<0.80 calculated from the cross-sectional CT image of L3 vertebra.

Primary Outcome Measures

Name	Time	Method
%EWL	6 month after surgery	Percentage excess weight loss is calculated as (initial weight - 6-month weight)/(initial weight - ideal weight) × 100%.

Secondary Outcome Measures

Name	Time	Method
%EWL	12 month after surgery	Percentage excess weight loss is calculated as (initial weight - 12-month weight)/(initial weight - ideal weight) × 100%.
%TWL	12 month after surgery	Percentage total weight loss is calculated as (initial weight - 12-month weight)/(initial weight) × 100%
EBMI	6 month after surgery	Excess BMI is calculated as(follow-up BMI - ideal BMI)
%WL	6 month after surgery	Percentage weight loss is calculated as (follow-up weight/initial weight) × 100%
MA II score	6 month after surgery	Moorhead-Ardelt QOL questionnaire is a six-item self-report questionnaire that assesses the patient's subjective impression of QOL,The total score ranges from -3 to +3 and defines five outcome groups: very poor, poor, fair, good, and very good. Good and very good outcomes were considered satisfactory.
BAROS score	6 month after surgery	The Bariatric Analysis and Reporting Outcome System(BAROS)combines the Moorhead-Ardelt QOL questionnaire with other data relevant to bariatric surgery, including the %EWL, improvement in comorbid conditions, and complications.A BAROS score ≤1 was considered a failure; \>1-3, fair; \>3-5, good; \>5-7, very good; and \>7, excellent.

Trial Locations

Locations (1)

Chang-ming Huang; 🇨🇳 Fuzhou, Fujian, China