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Endoscopic Sleeve GastroplastyNCT04264364

ESG vs LSG: Short-term Nutritional Outcomes

An observational study of Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy, run by King Saud University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laparoscopic sleeve gastrectomy and Endoscopic sleeve gastroplasty
Type of treatment
Surgery or procedure
How many people
57 participants
Where
1 siteSaudi Arabia
Study dates
16 Jun 2019to 25 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: 27 LSG patients 30 ESG patients

Who may be able to join

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

Who cannot join

  • Children (<18 years old)
  • Pregnant

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • New You Medical Center

    Riyadh, 13326

Other trials in Saudi Arabia

About this study

Official title: Endoscopic Sleeve Gastroplasty in Comparison With Laparoscopic Sleeve Gastrectomy in Terms of 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.

Read the detailed 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).

Being tested
Laparoscopic sleeve gastrectomy, Endoscopic sleeve gastroplasty
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve gastrectomyProcedure or surgery

    Bariatric surgical intervention

  • Endoscopic sleeve gastroplastyProcedure or surgery

    Endoscopic bariatric procedure

Study groups in NCT04264364
Study groupRoleWhat they receive
laparoscopic sleeve gastrectomyPatients who underwent laparoscopic sleeve gastrectomy
Receives: Procedure: Laparoscopic sleeve gastrectomy
endoscopic sleeve gastroplastyPatients who underwent endoscopic sleeve gastroplasty
Receives: Procedure: Endoscopic sleeve gastroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Loss

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

    Measured: 3 months

  2. Percentage of total weight loss (%TWL)

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

    Measured: 3 months

  3. 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])

    Measured: 3 months

  4. Waist Circumference

    Waist Circumference in centimeters

    Measured: 3 months

  5. body fat percentage change

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

    Measured: 3 months

  6. fat mass change

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

    Measured: 3 months

  7. 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

    Measured: 3 months

  8. 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

    Measured: 3 months

  9. 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

    Measured: 3 months

  10. 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

    Measured: 3 months

  11. 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.

    Measured: 3 months

  12. 24-hour dietary recall

    Assessment of nutritional intake with 24-hour dietary recall form

    Measured: 3 months

  13. 3-day dietary record

    Assessment of nutritional intake with 3-day dietary record

    Measured: 3 months

  14. 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.

    Measured: 3 months

  15. Cholesterol Biochemical assessment (laboratory assessment)

    Cholesterol in milligrams per deciliter (< 200 Desirable)

    Measured: 3 months

  16. Alanine Aminotransferase Biochemical assessment (laboratory assessment)

    Alanine Aminotransferase in units per liter (up to 33)

    Measured: 3 months

  17. Gamma glutamyl transferase Biochemical assessment (laboratory assessment)

    Gamma glutamyl transferase in units per liter (< 40)

    Measured: 3 months

  18. sodium Biochemical assessment (laboratory assessment)

    sodium in millimoles/liter (136-145)

    Measured: 3 months

  19. platelets Biochemical assessment (laboratory assessment)

    platelets in cmm (150.0-450.0)

    Measured: 3 months

  20. MCH Biochemical assessment (laboratory assessment)

    MCH in picograms per cell (25.00-32.00)

    Measured: 3 months

  21. potassium Biochemical assessment (laboratory assessment)

    potassium in millimoles/liter (3.5-5.1)

    Measured: 3 months

  22. MCV Biochemical assessment (laboratory assessment)

    MCV in femtoliters per cell (76.00-97.00)

    Measured: 3 months

  23. MCHC Biochemical assessment (laboratory assessment)

    MCHC in grams per deciliter (31.80-35.40)

    Measured: 3 months

  24. Chloride Biochemical assessment (laboratory assessment)

    Chloride in millimoles/liter (97-111)

    Measured: 3 months

  25. creatinine Biochemical assessment (laboratory assessment)

    creatinine in mg/dL (44-80)

    Measured: 3 months

  26. WBC Biochemical assessment (laboratory assessment)

    WBC in × 10^9/L (4.00-11.00)

    Measured: 3 months

  27. RBC Biochemical assessment (laboratory assessment)

    RBC in million mcL (3.80-5.80)

    Measured: 3 months

  28. HCT Biochemical assessment (laboratory assessment)

    HCT in % (36.00-46.00)

    Measured: 3 months

  29. serum glucose Biochemical assessment (laboratory assessment)

    serum glucose in mg/dL (70-150)

    Measured: 3 months

  30. serum TSH Biochemical assessment (laboratory assessment)

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

    Measured: 3 months

  31. hemoglobin Biochemical assessment (laboratory assessment)

    hemoglobin in grams per deciliter (12.00-16.00)

    Measured: 3 months

  32. Eosinophils Biochemical assessment (laboratory assessment)

    Eosinophils in cells per microliter (0.00-6.00)

    Measured: 3 months

  33. monocytes Biochemical assessment (laboratory assessment)

    monocytes in percent (0.00-13.70)

    Measured: 3 months

  34. INR plasma ratio Biochemical assessment (laboratory assessment)

    INR plasma ratio (no units)

    Measured: 3 months

  35. Basophils Biochemical assessment (laboratory assessment)

    Basophils in basophils per microliter (0.00-1.00)

    Measured: 3 months

  36. MPV Biochemical assessment (laboratory assessment)

    MPV in fl (7.20-11.10)

    Measured: 3 months

  37. RDW Biochemical assessment (laboratory assessment)

    RDW in % (12.40-16.20)

    Measured: 3 months

  38. lymphocytes Biochemical assessment (laboratory assessment)

    lymphocytes in % (15.00-50.00)

    Measured: 3 months

  39. neutrophils Biochemical assessment (laboratory assessment)

    neutrophils in cells/µL (40.00-75.00)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start16 Jun 2019
  3. Primary completion25 Nov 2019
  4. Study completion25 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264364
Sponsor's protocol ID
ESGvsLSG
Status last verified
Feb 2020
First submitted
30 Jan 2020
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy, run by King Saud University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Loss (time frame: 3 months). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04264364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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