ESG vs LSG: Short-term Nutritional Outcomes

February 9, 2020 updated by: Ghadah AlGhafees, King Saud University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 13326
        • New You Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

27 LSG patients 30 ESG patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Children (<18 years old)
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
laparoscopic sleeve gastrectomy
Patients who underwent laparoscopic sleeve gastrectomy
Procedure: Laparoscopic sleeve gastrectomy
Bariatric surgical intervention
endoscopic sleeve gastroplasty
Patients who underwent endoscopic sleeve gastroplasty
Procedure: Endoscopic sleeve gastroplasty
Endoscopic bariatric procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 3 months
Weight Loss in kilograms (baseline weight in kilogram - follow-up weight in kilogram)
3 months
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 months
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])
3 months
Waist Circumference
Time Frame: 3 months
Waist Circumference in centimeters
3 months
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
3 months
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
3 months
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
3 months
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
3 months
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
3 months
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
3 months
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.
3 months
24-hour dietary recall
Time Frame: 3 months
Assessment of nutritional intake with 24-hour dietary recall form
3 months
3-day dietary record
Time Frame: 3 months
Assessment of nutritional intake with 3-day dietary record
3 months
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.
3 months
Cholesterol Biochemical assessment (laboratory assessment)
Time Frame: 3 months
Cholesterol in milligrams per deciliter (< 200 Desirable)
3 months
Alanine Aminotransferase Biochemical assessment (laboratory assessment)
Time Frame: 3 months
Alanine Aminotransferase in units per liter (up to 33)
3 months
Gamma glutamyl transferase Biochemical assessment (laboratory assessment)
Time Frame: 3 months
Gamma glutamyl transferase in units per liter (< 40)
3 months
sodium Biochemical assessment (laboratory assessment)
Time Frame: 3 months
sodium in millimoles/liter (136-145)
3 months
platelets Biochemical assessment (laboratory assessment)
Time Frame: 3 months
platelets in cmm (150.0-450.0)
3 months
MCH Biochemical assessment (laboratory assessment)
Time Frame: 3 months
MCH in picograms per cell (25.00-32.00)
3 months
potassium Biochemical assessment (laboratory assessment)
Time Frame: 3 months
potassium in millimoles/liter (3.5-5.1)
3 months
MCV Biochemical assessment (laboratory assessment)
Time Frame: 3 months
MCV in femtoliters per cell (76.00-97.00)
3 months
MCHC Biochemical assessment (laboratory assessment)
Time Frame: 3 months
MCHC in grams per deciliter (31.80-35.40)
3 months
Chloride Biochemical assessment (laboratory assessment)
Time Frame: 3 months
Chloride in millimoles/liter (97-111)
3 months
creatinine Biochemical assessment (laboratory assessment)
Time Frame: 3 months
creatinine in mg/dL (44-80)
3 months
WBC Biochemical assessment (laboratory assessment)
Time Frame: 3 months
WBC in × 10^9/L (4.00-11.00)
3 months
RBC Biochemical assessment (laboratory assessment)
Time Frame: 3 months
RBC in million mcL (3.80-5.80)
3 months
HCT Biochemical assessment (laboratory assessment)
Time Frame: 3 months
HCT in % (36.00-46.00)
3 months
serum glucose Biochemical assessment (laboratory assessment)
Time Frame: 3 months
serum glucose in mg/dL (70-150)
3 months
serum TSH Biochemical assessment (laboratory assessment)
Time Frame: 3 months
serum TSH in milli-international units per liter (0.38-5.33)
3 months
hemoglobin Biochemical assessment (laboratory assessment)
Time Frame: 3 months
hemoglobin in grams per deciliter (12.00-16.00)
3 months
Eosinophils Biochemical assessment (laboratory assessment)
Time Frame: 3 months
Eosinophils in cells per microliter (0.00-6.00)
3 months
monocytes Biochemical assessment (laboratory assessment)
Time Frame: 3 months
monocytes in percent (0.00-13.70)
3 months
INR plasma ratio Biochemical assessment (laboratory assessment)
Time Frame: 3 months
INR plasma ratio (no units)
3 months
Basophils Biochemical assessment (laboratory assessment)
Time Frame: 3 months
Basophils in basophils per microliter (0.00-1.00)
3 months
MPV Biochemical assessment (laboratory assessment)
Time Frame: 3 months
MPV in fl (7.20-11.10)
3 months
RDW Biochemical assessment (laboratory assessment)
Time Frame: 3 months
RDW in % (12.40-16.20)
3 months
lymphocytes Biochemical assessment (laboratory assessment)
Time Frame: 3 months
lymphocytes in % (15.00-50.00)
3 months
neutrophils Biochemical assessment (laboratory assessment)
Time Frame: 3 months
neutrophils in cells/µL (40.00-75.00)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Saud University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King Saud Medical City

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ghadah M AlGhafees, BSc, King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESGvsLSG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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