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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04264364
Other study ID # ESGvsLSG
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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