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临床试验/NCT04880902
NCT04880902已完成不适用

Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy: Effect of the Pouch Size on Excessive Weight Loss and Weight Regain

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年11月1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
40
试验地点
2
主要终点
Gastric volume after surgery

研究概览

简要总结

This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice computer tomography.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI of > 40 kg/m 2 or > 35 kg/m2 with comorbidities e.g. hypertension and type 2 DM.
  • All patients failed in supervised conservative management for obesity for at least 2 years.

排除标准

  • BMI > 60
  • previous bariatric surgery
  • symptomatic reflux oesophagitis disease, gastric pathology (tumor, active peptic ulcer)
  • Significant psychological disorder, active alcohol or substance abuse
  • severe eating disorders (bulimia)
  • severe systemic disease making anesthesia or surgery prohibitively risky (American Society of Anesthesiologists (ASA) class IV

结局指标

主要结局

Gastric volume after surgery

时间窗: 1 month

gastric reservoir volume after performance of laparoscopic sleeve gastrectomy

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

Mohamed Ahmed Elkhoby

Dr, assistant lecturer of General Surgery

Kafrelsheikh University

研究点 (2)

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