Endoscopic Sleeve Gastroplasty in Comparison With Laparoscopic Sleeve Gastrectomy in Terms of Short-Term Nutritional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Percentage of excess weight loss (%EWL)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years old)
- •Willingness and ability to participate
- •Males and females
- •Non-pregnant
排除标准
- •Children (<18 years old)
结局指标
主要结局
Percentage of excess weight loss (%EWL)
时间窗: 3 months
%EWL = \[percentage of weight lost compared with excess weight, which is defined as baseline weight in kilogram - the weight corresponding to a BMI of 25 kg/m\^2 in kilogram\])
Waist Circumference
时间窗: 3 months
Waist Circumference in centimeters
body fat percentage change
时间窗: 3 months
change in body fat percentage between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device
fat mass change
时间窗: 3 months
change in fat mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device
fat mass index change
时间窗: 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
fat free mass change
时间窗: 3 months
change in fat free mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device
Weight Loss
时间窗: 3 months
Weight Loss in kilograms (baseline weight in kilogram - follow-up weight in kilogram)
Percentage of total weight loss (%TWL)
时间窗: 3 months
%TWL = \[(baseline weight in kilogram - weight at 3 months in kilogram) ÷ baseline weight in kilogram\]
fat free mass index change
时间窗: 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
skeletal muscle mass change
时间窗: 3 months
change in skeletal muscle mass in kilograms between baseline and follow-up visits as calculated by a calibrated bioelectrical impedance device
Dietary habits
时间窗: 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.
24-hour dietary recall
时间窗: 3 months
Assessment of nutritional intake with 24-hour dietary recall form
3-day dietary record
时间窗: 3 months
Assessment of nutritional intake with 3-day dietary record
Change in quality of life after procedure
时间窗: 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.
Cholesterol Biochemical assessment (laboratory assessment)
时间窗: 3 months
Cholesterol in milligrams per deciliter (\< 200 Desirable)
Alanine Aminotransferase Biochemical assessment (laboratory assessment)
时间窗: 3 months
Alanine Aminotransferase in units per liter (up to 33)
MCV Biochemical assessment (laboratory assessment)
时间窗: 3 months
MCV in femtoliters per cell (76.00-97.00)
MCHC Biochemical assessment (laboratory assessment)
时间窗: 3 months
MCHC in grams per deciliter (31.80-35.40)
Gamma glutamyl transferase Biochemical assessment (laboratory assessment)
时间窗: 3 months
Gamma glutamyl transferase in units per liter (\< 40)
sodium Biochemical assessment (laboratory assessment)
时间窗: 3 months
sodium in millimoles/liter (136-145)
platelets Biochemical assessment (laboratory assessment)
时间窗: 3 months
platelets in cmm (150.0-450.0)
MCH Biochemical assessment (laboratory assessment)
时间窗: 3 months
MCH in picograms per cell (25.00-32.00)
potassium Biochemical assessment (laboratory assessment)
时间窗: 3 months
potassium in millimoles/liter (3.5-5.1)
Chloride Biochemical assessment (laboratory assessment)
时间窗: 3 months
Chloride in millimoles/liter (97-111)
creatinine Biochemical assessment (laboratory assessment)
时间窗: 3 months
creatinine in mg/dL (44-80)
WBC Biochemical assessment (laboratory assessment)
时间窗: 3 months
WBC in × 10\^9/L (4.00-11.00)
RBC Biochemical assessment (laboratory assessment)
时间窗: 3 months
RBC in million mcL (3.80-5.80)
HCT Biochemical assessment (laboratory assessment)
时间窗: 3 months
HCT in % (36.00-46.00)
serum glucose Biochemical assessment (laboratory assessment)
时间窗: 3 months
serum glucose in mg/dL (70-150)
serum TSH Biochemical assessment (laboratory assessment)
时间窗: 3 months
serum TSH in milli-international units per liter (0.38-5.33)
hemoglobin Biochemical assessment (laboratory assessment)
时间窗: 3 months
hemoglobin in grams per deciliter (12.00-16.00)
Eosinophils Biochemical assessment (laboratory assessment)
时间窗: 3 months
Eosinophils in cells per microliter (0.00-6.00)
monocytes Biochemical assessment (laboratory assessment)
时间窗: 3 months
monocytes in percent (0.00-13.70)
lymphocytes Biochemical assessment (laboratory assessment)
时间窗: 3 months
lymphocytes in % (15.00-50.00)
neutrophils Biochemical assessment (laboratory assessment)
时间窗: 3 months
neutrophils in cells/µL (40.00-75.00)
INR plasma ratio Biochemical assessment (laboratory assessment)
时间窗: 3 months
INR plasma ratio (no units)
Basophils Biochemical assessment (laboratory assessment)
时间窗: 3 months
Basophils in basophils per microliter (0.00-1.00)
MPV Biochemical assessment (laboratory assessment)
时间窗: 3 months
MPV in fl (7.20-11.10)
RDW Biochemical assessment (laboratory assessment)
时间窗: 3 months
RDW in % (12.40-16.20)
次要结局
未报告次要终点
研究者
Ghadah AlGhafees
Clinical Nutrition Master's Student
King Saud University
