ESG vs LSG: Short-term Nutritional Outcomes

Completed

• Conditions: Endoscopic Sleeve Gastroplasty; Obesity; Laparoscopic Sleeve Gastrectomy
• Interventions: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Endoscopic sleeve gastroplasty

• Registration Number: NCT04264364
• Lead Sponsor: King Saud University

Brief Summary

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.

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 Timeline

• Study Start: 2019-06-16
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Study First Submitted: 2020-01-30
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-09
• Last Update Submitted: 2020-02-09
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

Exclusion Criteria

• Children (<18 years old)
• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic sleeve gastrectomy	Laparoscopic sleeve gastrectomy	Patients who underwent laparoscopic sleeve gastrectomy
endoscopic sleeve gastroplasty	Endoscopic sleeve gastroplasty	Patients who underwent endoscopic sleeve gastroplasty

Primary Outcome Measures

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

Trial Locations

Locations (1)

New You Medical Center; 🇸🇦 Riyadh, Saudi Arabia