ESG vs LSG: Short-term Nutritional Outcomes

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264364
• Other study ID #: ESGvsLSG
• Status: Completed
• Start date: June 16, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: February 2020
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (= 18 years old)

• Willingness and ability to participate

• Males and females

• Non-pregnant

Exclusion Criteria:

• Children (<18 years old)

• Pregnant

Related Conditions & MeSH terms

• Endoscopic Sleeve Gastroplasty
• Laparoscopic Sleeve Gastrectomy
• Obesity

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
Bariatric surgical intervention
• Endoscopic sleeve gastroplasty
Endoscopic bariatric procedure

Locations

Country	Name	City	State
Saudi Arabia	New You Medical Center	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	King Saud Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Weight Loss in kilograms (baseline weight in kilogram - follow-up weight in kilogram)	3 months
Primary	Percentage of total weight loss (%TWL)	%TWL = [(baseline weight in kilogram - weight at 3 months in kilogram) ÷ baseline weight in kilogram]	3 months
Primary	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
Primary	Waist Circumference	Waist Circumference in centimeters	3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	24-hour dietary recall	Assessment of nutritional intake with 24-hour dietary recall form	3 months
Primary	3-day dietary record	Assessment of nutritional intake with 3-day dietary record	3 months
Primary	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
Primary	Cholesterol Biochemical assessment (laboratory assessment)	Cholesterol in milligrams per deciliter (< 200 Desirable)	3 months
Primary	Alanine Aminotransferase Biochemical assessment (laboratory assessment)	Alanine Aminotransferase in units per liter (up to 33)	3 months
Primary	Gamma glutamyl transferase Biochemical assessment (laboratory assessment)	Gamma glutamyl transferase in units per liter (< 40)	3 months
Primary	sodium Biochemical assessment (laboratory assessment)	sodium in millimoles/liter (136-145)	3 months
Primary	platelets Biochemical assessment (laboratory assessment)	platelets in cmm (150.0-450.0)	3 months
Primary	MCH Biochemical assessment (laboratory assessment)	MCH in picograms per cell (25.00-32.00)	3 months
Primary	potassium Biochemical assessment (laboratory assessment)	potassium in millimoles/liter (3.5-5.1)	3 months
Primary	MCV Biochemical assessment (laboratory assessment)	MCV in femtoliters per cell (76.00-97.00)	3 months
Primary	MCHC Biochemical assessment (laboratory assessment)	MCHC in grams per deciliter (31.80-35.40)	3 months
Primary	Chloride Biochemical assessment (laboratory assessment)	Chloride in millimoles/liter (97-111)	3 months
Primary	creatinine Biochemical assessment (laboratory assessment)	creatinine in mg/dL (44-80)	3 months
Primary	WBC Biochemical assessment (laboratory assessment)	WBC in × 10^9/L (4.00-11.00)	3 months
Primary	RBC Biochemical assessment (laboratory assessment)	RBC in million mcL (3.80-5.80)	3 months
Primary	HCT Biochemical assessment (laboratory assessment)	HCT in % (36.00-46.00)	3 months
Primary	serum glucose Biochemical assessment (laboratory assessment)	serum glucose in mg/dL (70-150)	3 months
Primary	serum TSH Biochemical assessment (laboratory assessment)	serum TSH in milli-international units per liter (0.38-5.33)	3 months
Primary	hemoglobin Biochemical assessment (laboratory assessment)	hemoglobin in grams per deciliter (12.00-16.00)	3 months
Primary	Eosinophils Biochemical assessment (laboratory assessment)	Eosinophils in cells per microliter (0.00-6.00)	3 months
Primary	monocytes Biochemical assessment (laboratory assessment)	monocytes in percent (0.00-13.70)	3 months
Primary	INR plasma ratio Biochemical assessment (laboratory assessment)	INR plasma ratio (no units)	3 months
Primary	Basophils Biochemical assessment (laboratory assessment)	Basophils in basophils per microliter (0.00-1.00)	3 months
Primary	MPV Biochemical assessment (laboratory assessment)	MPV in fl (7.20-11.10)	3 months
Primary	RDW Biochemical assessment (laboratory assessment)	RDW in % (12.40-16.20)	3 months
Primary	lymphocytes Biochemical assessment (laboratory assessment)	lymphocytes in % (15.00-50.00)	3 months
Primary	neutrophils Biochemical assessment (laboratory assessment)	neutrophils in cells/µL (40.00-75.00)	3 months