Clinical trial NCT04264364: ESG vs LSG: Short-term Nutritional Outcomes
Official title: Endoscopic Sleeve Gastroplasty in Comparison With Laparoscopic Sleeve Gastrectomy in Terms of Short-Term Nutritional Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Sleeve Gastroplasty
Laparoscopic Sleeve Gastrectomy
Obesity
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: King Saud Medical City
First posted: 2020-02-11
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 27 LSG patients 30 ESG patients

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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Children (\<18 years old)
* Pregnant

Primary outcomes:
measure: Weight Loss
timeFrame: 3 months
measure: Percentage of total weight loss (%TWL)
timeFrame: 3 months
measure: Percentage of excess weight loss (%EWL)
timeFrame: 3 months
measure: Waist Circumference
timeFrame: 3 months
measure: body fat percentage change
timeFrame: 3 months
measure: fat mass change
timeFrame: 3 months
measure: fat mass index change
timeFrame: 3 months
measure: fat free mass change
timeFrame: 3 months
measure: fat free mass index change
timeFrame: 3 months
measure: skeletal muscle mass change
timeFrame: 3 months
measure: Dietary habits
timeFrame: 3 months
measure: 24-hour dietary recall
timeFrame: 3 months
measure: 3-day dietary record
timeFrame: 3 months
measure: Change in quality of life after procedure
timeFrame: 3 months
measure: Cholesterol Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: Alanine Aminotransferase Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: Gamma glutamyl transferase Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: sodium Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: platelets Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: MCH Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: potassium Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: MCV Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: MCHC Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: Chloride Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: creatinine Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: WBC Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: RBC Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: HCT Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: serum glucose Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: serum TSH Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: hemoglobin Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: Eosinophils Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: monocytes Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: INR plasma ratio Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: Basophils Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: MPV Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: RDW Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: lymphocytes Biochemical assessment (laboratory assessment)
timeFrame: 3 months
measure: neutrophils Biochemical assessment (laboratory assessment)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: New You Medical Center
Study officials:
affiliation: King Saud University
name: Ghadah M AlGhafees, BSc
role: PRINCIPAL_INVESTIGATOR
References: