ESG vs LSG: Short-term Nutritional Outcomes

Endoscopic Sleeve Gastroplasty in Comparison With Laparoscopic Sleeve Gastrectomy in Terms of Short-Term Nutritional Outcomes

To assess endoscopic sleeve gastroplasty in comparison to laparoscopic sleeve gastrectomy before and 3 months after the procedure in terms of multiple nutrition-related factors, quality of life, weight and other related parameters.

Study Overview

• Status: Completed
• Conditions: Obesity; Laparoscopic Sleeve Gastrectomy; Endoscopic Sleeve Gastroplasty
• Intervention / Treatment: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Endoscopic sleeve gastroplasty

Detailed Description

This will be a short-term prospective cohort study, single-center study (NewYou clinical center - Riyadh). A total of 15 endoscopic sleeve gastroplasty patients will be matched with 15 laparoscopic sleeve gastrectomy patients by age, gender and BMI. Total sample size is 30 patients. Sample size was selected based on literature, considering the sample will be surgical patients and based on booked patients in the clinic. A multidisciplinary team will provide post-procedure care (including post-surgery diet stages protocol given by the center).

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 13326
    • New You Medical Center

Participation Criteria

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

27 LSG patients 30 ESG patients

Description

Inclusion Criteria:

• Adult (≥ 18 years old)
• Willingness and ability to participate
• Males and females
• Non-pregnant

Exclusion Criteria:

• Children (<18 years old)
• Pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic sleeve gastrectomy; Patients who underwent laparoscopic sleeve gastrectomy	Procedure: Laparoscopic sleeve gastrectomy; Bariatric surgical intervention
endoscopic sleeve gastroplasty; Patients who underwent endoscopic sleeve gastroplasty	Procedure: Endoscopic sleeve gastroplasty; Endoscopic bariatric procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	Weight Loss in kilograms (baseline weight in kilogram - follow-up weight in kilogram)	3 months
Percentage of total weight loss (%TWL)	%TWL = [(baseline weight in kilogram - weight at 3 months in kilogram) ÷ baseline weight in kilogram]	3 months
Percentage of excess weight loss (%EWL)	%EWL = [percentage of weight lost compared with excess weight, which is defined as baseline weight in kilogram - the weight corresponding to a BMI of 25 kg/m^2 in kilogram])	3 months
Waist Circumference	Waist Circumference in centimeters	3 months
body fat percentage change	change in body fat percentage between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device	3 months
fat mass change	change in fat mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device	3 months
fat mass index change	change in fat mass index in kg/m^2 between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device	3 months
fat free mass change	change in fat free mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device	3 months
fat free mass index change	change in fat free mass index in kg/m^2 between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device	3 months
skeletal muscle mass change	change in skeletal muscle mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device	3 months
Dietary habits	Assessment of dietary habits using the How Healthy Is Your Diet questionnaire, developed by the British Heart Foundation 2012 The score is from 0 minimum to 29. Higher score correlates with better dietary habits.	3 months
24-hour dietary recall	Assessment of nutritional intake with 24-hour dietary recall form	3 months
3-day dietary record	Assessment of nutritional intake with 3-day dietary record	3 months
Change in quality of life after procedure	Moorehead-Ardelt Quality of Life Questionnaire II scoring using Moorehead-Ardelt Quality of Life Questionnaire II Self Esteem and Activity Levels SCORING KEY minimum score is -3 and maximum score is 3 a higher score means a better outcome.	3 months
Cholesterol Biochemical assessment (laboratory assessment)	Cholesterol in milligrams per deciliter (< 200 Desirable)	3 months
Alanine Aminotransferase Biochemical assessment (laboratory assessment)	Alanine Aminotransferase in units per liter (up to 33)	3 months
Gamma glutamyl transferase Biochemical assessment (laboratory assessment)	Gamma glutamyl transferase in units per liter (< 40)	3 months
sodium Biochemical assessment (laboratory assessment)	sodium in millimoles/liter (136-145)	3 months
platelets Biochemical assessment (laboratory assessment)	platelets in cmm (150.0-450.0)	3 months
MCH Biochemical assessment (laboratory assessment)	MCH in picograms per cell (25.00-32.00)	3 months
potassium Biochemical assessment (laboratory assessment)	potassium in millimoles/liter (3.5-5.1)	3 months
MCV Biochemical assessment (laboratory assessment)	MCV in femtoliters per cell (76.00-97.00)	3 months
MCHC Biochemical assessment (laboratory assessment)	MCHC in grams per deciliter (31.80-35.40)	3 months
Chloride Biochemical assessment (laboratory assessment)	Chloride in millimoles/liter (97-111)	3 months
creatinine Biochemical assessment (laboratory assessment)	creatinine in mg/dL (44-80)	3 months
WBC Biochemical assessment (laboratory assessment)	WBC in × 10^9/L (4.00-11.00)	3 months
RBC Biochemical assessment (laboratory assessment)	RBC in million mcL (3.80-5.80)	3 months
HCT Biochemical assessment (laboratory assessment)	HCT in % (36.00-46.00)	3 months
serum glucose Biochemical assessment (laboratory assessment)	serum glucose in mg/dL (70-150)	3 months
serum TSH Biochemical assessment (laboratory assessment)	serum TSH in milli-international units per liter (0.38-5.33)	3 months
hemoglobin Biochemical assessment (laboratory assessment)	hemoglobin in grams per deciliter (12.00-16.00)	3 months
Eosinophils Biochemical assessment (laboratory assessment)	Eosinophils in cells per microliter (0.00-6.00)	3 months
monocytes Biochemical assessment (laboratory assessment)	monocytes in percent (0.00-13.70)	3 months
INR plasma ratio Biochemical assessment (laboratory assessment)	INR plasma ratio (no units)	3 months
Basophils Biochemical assessment (laboratory assessment)	Basophils in basophils per microliter (0.00-1.00)	3 months
MPV Biochemical assessment (laboratory assessment)	MPV in fl (7.20-11.10)	3 months
RDW Biochemical assessment (laboratory assessment)	RDW in % (12.40-16.20)	3 months
lymphocytes Biochemical assessment (laboratory assessment)	lymphocytes in % (15.00-50.00)	3 months
neutrophils Biochemical assessment (laboratory assessment)	neutrophils in cells/µL (40.00-75.00)	3 months

Collaborators and Investigators

• Sponsor: King Saud University
• Collaborators: King Saud Medical City
• Investigators: Principal Investigator: Ghadah M AlGhafees, BSc, King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2019
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ESGvsLSG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No