ESG vs LSG: Short-term Nutritional Outcomes

NCT04264364 | Completed DMC

• 1 other identifier: ESGvsLSG
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Sleeve Gastroplasty; Laparoscopic Sleeve Gastrectomy; Obesity

Outcome Measures

Primary Outcomes (39)

• 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

Study Arms (2)

laparoscopic sleeve gastrectomy

Patients who underwent laparoscopic sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomy

endoscopic sleeve gastroplasty

Patients who underwent endoscopic sleeve gastroplasty

Procedure: Endoscopic sleeve gastroplasty

Interventions

Laparoscopic sleeve gastrectomy PROCEDURE

Bariatric surgical intervention

laparoscopic sleeve gastrectomy

Endoscopic sleeve gastroplasty PROCEDURE

Endoscopic bariatric procedure

endoscopic sleeve gastroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

27 LSG patients 30 ESG patients

You may qualify if:

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

You may not qualify if:

• Children (\<18 years old)
• Pregnant

Sponsors & Collaborators

• King Saud University: lead
• King Saud Medical City: collaborator

Study Sites (1)

New You Medical Center

Riyadh, 13326, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghadah M AlGhafees, BSc

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nutrition Master's Student

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 11, 2020
• Study Start: June 16, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

SA (1)