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临床试验/NCT04650373
NCT04650373已完成不适用

Long-term Durability of Weight Loss After Bariatric Surgery; A Retrospective Study

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月17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
100
试验地点
1
主要终点
weight-change percentage at follow-up

研究概览

简要总结

The present study is a retrospective cohort study. Patients older than 18 years of age and underwent Roux-en-Y gastric bypass (RYGB) surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one and the clinical events after surgery.

详细描述

This is a retrospective cohort study. The sample size of our study includes one hundred case older than 18 years of age and underwent RYGB surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment, died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. Data was collected taking in to account each patient history (age, sex, length, weight, BMI, occupation, marital status, and comorbidities) and weight record in every visit from measurements statistics. Outcomes: The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one. The secondary effects including the clinical events after surgery, micronutrient levels, incidence of diabetes, hypertension, and dyslipidemia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients equal or over 18 years old
  • BMI more than 40
  • Complete follow up

排除标准

  • No complete follow up
  • Age less than 18 or more than 80

结局指标

主要结局

weight-change percentage at follow-up

时间窗: 1 year

Weight loss or gain in kilogram after surgery is evaluated.

Clinical Events, Diabetes Miletus

时间窗: 1 year

The secondary effects of the clinical events after surgery including incidence of diabetes disease (DM) is measured using the blood glucose level. Fasting blood glucose level more than 7.1 mmol/L is considered posutive for DM

Clinical Events, Hypertension

时间窗: 1 year

Arterial blood pressure is followed up regularly, three consequences increase of the blood pressure more than 140 mm Hg systolic and 90 mm Hg diastolic, is positive for hypertension

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

Abdulkarim Hasan

Pathologist and Laboratory Director

Al-Azhar University

研究点 (1)

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