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Completed

NCT Number: NCT04264364

ESG vs LSG: Short-term Nutritional Outcomes

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.

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Key information

Conditions

Endoscopic Sleeve Gastroplasty Body Weight Laparoscopic Sleeve Gastrectomy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New You Medical Center

Riyadh, 13326, Saudi Arabia

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children (<18 years old)
  • Pregnant

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

Bariatric surgical intervention

Endoscopic Sleeve Gastroplasty

Procedure

Endoscopic bariatric procedure

Primary outcomes

  1. Weight Loss

    Time frame: 3 months

    Weight Loss in kilograms (baseline weight in kilogram - follow-up weight in kilogram)

  2. Percentage of total weight loss (%TWL)

    Time frame: 3 months

    %TWL = [(baseline weight in kilogram - weight at 3 months in kilogram) ÷ baseline weight in kilogram]

  3. Percentage of excess weight loss (%EWL)

    Time frame: 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])

  4. Waist Circumference

    Time frame: 3 months

    Waist Circumference in centimeters

  5. body fat percentage change

    Time frame: 3 months

    change in body fat percentage between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device

  6. fat mass change

    Time frame: 3 months

    change in fat mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device

  7. fat mass index change

    Time frame: 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

  8. fat free mass change

    Time frame: 3 months

    change in fat free mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device

  9. fat free mass index change

    Time frame: 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

  10. skeletal muscle mass change

    Time frame: 3 months

    change in skeletal muscle mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device

  11. Dietary habits

    Time frame: 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.

  12. 24-hour dietary recall

    Time frame: 3 months

    Assessment of nutritional intake with 24-hour dietary recall form

  13. 3-day dietary record

    Time frame: 3 months

    Assessment of nutritional intake with 3-day dietary record

  14. Change in quality of life after procedure

    Time frame: 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.

  15. Cholesterol Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    Cholesterol in milligrams per deciliter (< 200 Desirable)

  16. Alanine Aminotransferase Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    Alanine Aminotransferase in units per liter (up to 33)

  17. Gamma glutamyl transferase Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    Gamma glutamyl transferase in units per liter (< 40)

  18. sodium Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    sodium in millimoles/liter (136-145)

  19. platelets Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    platelets in cmm (150.0-450.0)

  20. MCH Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    MCH in picograms per cell (25.00-32.00)

  21. potassium Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    potassium in millimoles/liter (3.5-5.1)

  22. MCV Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    MCV in femtoliters per cell (76.00-97.00)

  23. MCHC Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    MCHC in grams per deciliter (31.80-35.40)

  24. Chloride Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    Chloride in millimoles/liter (97-111)

  25. creatinine Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    creatinine in mg/dL (44-80)

  26. WBC Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    WBC in × 10^9/L (4.00-11.00)

  27. RBC Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    RBC in million mcL (3.80-5.80)

  28. HCT Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    HCT in % (36.00-46.00)

  29. serum glucose Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    serum glucose in mg/dL (70-150)

  30. serum TSH Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    serum TSH in milli-international units per liter (0.38-5.33)

  31. hemoglobin Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    hemoglobin in grams per deciliter (12.00-16.00)

  32. Eosinophils Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    Eosinophils in cells per microliter (0.00-6.00)

  33. monocytes Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    monocytes in percent (0.00-13.70)

  34. INR plasma ratio Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    INR plasma ratio (no units)

  35. Basophils Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    Basophils in basophils per microliter (0.00-1.00)

  36. MPV Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    MPV in fl (7.20-11.10)

  37. RDW Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    RDW in % (12.40-16.20)

  38. lymphocytes Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    lymphocytes in % (15.00-50.00)

  39. neutrophils Biochemical assessment (laboratory assessment)

    Time frame: 3 months

    neutrophils in cells/µL (40.00-75.00)

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • King Saud Medical City

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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