ESG vs LSG: Short-term Nutritional Outcomes

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, Obesity

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy
* Procedure: Endoscopic sleeve gastroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 18 years old) Willingness and ability to participate Males and females Non-pregnant Exclusion Criteria: Children (<18 years old) Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| laparoscopic sleeve gastrectomy<br>Patients who underwent laparoscopic sleeve gastrectomy | Procedure: Laparoscopic sleeve gastrectomy<br>* Bariatric surgical intervention<br>|
| endoscopic sleeve gastroplasty<br>Patients who underwent endoscopic sleeve gastroplasty | Procedure: Endoscopic sleeve gastroplasty<br>* Endoscopic bariatric procedure<br>|

What is the study measuring?
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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 |