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临床试验/NCT04264364
NCT04264364已完成不适用

Endoscopic Sleeve Gastroplasty in Comparison With Laparoscopic Sleeve Gastrectomy in Terms of Short-Term Nutritional Outcomes

King Saud University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年6月16日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghadah AlGhafees

Clinical Nutrition Master's Student

King Saud University

研究点 (1)

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