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.
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
OBSERVATIONAL
Enrollment
57
Bariatric surgical intervention
Endoscopic bariatric procedure
New You Medical Center
Riyadh, Saudi Arabia
Weight Loss
Weight Loss in kilograms (baseline weight in kilogram - follow-up weight in kilogram)
Time frame: 3 months
Percentage of total weight loss (%TWL)
%TWL = \[(baseline weight in kilogram - weight at 3 months in kilogram) ÷ baseline weight in kilogram\]
Time frame: 3 months
Percentage of excess weight loss (%EWL)
%EWL = \[percentage of weight lost compared with excess weight, which is defined as baseline weight in kilogram - the weight corresponding to a BMI of 25 kg/m\^2 in kilogram\])
Time frame: 3 months
Waist Circumference
Waist Circumference in centimeters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 3 months
24-hour dietary recall
Assessment of nutritional intake with 24-hour dietary recall form
Time frame: 3 months
3-day dietary record
Assessment of nutritional intake with 3-day dietary record
Time frame: 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.
Time frame: 3 months
Cholesterol Biochemical assessment (laboratory assessment)
Cholesterol in milligrams per deciliter (\< 200 Desirable)
Time frame: 3 months
Alanine Aminotransferase Biochemical assessment (laboratory assessment)
Alanine Aminotransferase in units per liter (up to 33)
Time frame: 3 months
Gamma glutamyl transferase Biochemical assessment (laboratory assessment)
Gamma glutamyl transferase in units per liter (\< 40)
Time frame: 3 months
sodium Biochemical assessment (laboratory assessment)
sodium in millimoles/liter (136-145)
Time frame: 3 months
platelets Biochemical assessment (laboratory assessment)
platelets in cmm (150.0-450.0)
Time frame: 3 months
MCH Biochemical assessment (laboratory assessment)
MCH in picograms per cell (25.00-32.00)
Time frame: 3 months
potassium Biochemical assessment (laboratory assessment)
potassium in millimoles/liter (3.5-5.1)
Time frame: 3 months
MCV Biochemical assessment (laboratory assessment)
MCV in femtoliters per cell (76.00-97.00)
Time frame: 3 months
MCHC Biochemical assessment (laboratory assessment)
MCHC in grams per deciliter (31.80-35.40)
Time frame: 3 months
Chloride Biochemical assessment (laboratory assessment)
Chloride in millimoles/liter (97-111)
Time frame: 3 months
creatinine Biochemical assessment (laboratory assessment)
creatinine in mg/dL (44-80)
Time frame: 3 months
WBC Biochemical assessment (laboratory assessment)
WBC in × 10\^9/L (4.00-11.00)
Time frame: 3 months
RBC Biochemical assessment (laboratory assessment)
RBC in million mcL (3.80-5.80)
Time frame: 3 months
HCT Biochemical assessment (laboratory assessment)
HCT in % (36.00-46.00)
Time frame: 3 months
serum glucose Biochemical assessment (laboratory assessment)
serum glucose in mg/dL (70-150)
Time frame: 3 months
serum TSH Biochemical assessment (laboratory assessment)
serum TSH in milli-international units per liter (0.38-5.33)
Time frame: 3 months
hemoglobin Biochemical assessment (laboratory assessment)
hemoglobin in grams per deciliter (12.00-16.00)
Time frame: 3 months
Eosinophils Biochemical assessment (laboratory assessment)
Eosinophils in cells per microliter (0.00-6.00)
Time frame: 3 months
monocytes Biochemical assessment (laboratory assessment)
monocytes in percent (0.00-13.70)
Time frame: 3 months
INR plasma ratio Biochemical assessment (laboratory assessment)
INR plasma ratio (no units)
Time frame: 3 months
Basophils Biochemical assessment (laboratory assessment)
Basophils in basophils per microliter (0.00-1.00)
Time frame: 3 months
MPV Biochemical assessment (laboratory assessment)
MPV in fl (7.20-11.10)
Time frame: 3 months
RDW Biochemical assessment (laboratory assessment)
RDW in % (12.40-16.20)
Time frame: 3 months
lymphocytes Biochemical assessment (laboratory assessment)
lymphocytes in % (15.00-50.00)
Time frame: 3 months
neutrophils Biochemical assessment (laboratory assessment)
neutrophils in cells/µL (40.00-75.00)
Time frame: 3 months