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临床试验/NCT03486691
NCT03486691已完成不适用

Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery

Minia University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
intraoperative maximum diameter of left lobe of the liver

研究概览

简要总结

the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty

详细描述

the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the other group ultrasound not routinely done.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •Morbidly obese patient with BMI more than 40 with or without co-morbidity
  • •Morbidly obese patient with BMI more than 35 with co-morbidity

排除标准

  • •Unfit patients for laparoscopy
  • •patients refuse to share in the study
  • •revisional surgery for obesity
  • •previous upper abdominal surgery

研究组 & 干预措施

Control group

Active Comparator

Control group without routine measurement of left lobe

干预措施: control group (Other)

preoperative left lobe measurement

Experimental

routine preoperative left lobe measurement

干预措施: Routine measurement of left lobe (Other)

结局指标

主要结局

intraoperative maximum diameter of left lobe of the liver

时间窗: 4 hours

intraoperative maximum diameter of left lobe of the liver in centimeter using intraoperative tape

score of difficulty

时间窗: 6 hours

score of difficulty from:exposure of the hiatus, retraction of the liver and operative time

次要结局

  • early postoperative complications(2 weeks)
  • incidence of intraoperative complications(3 days)
  • operative time(6 hours)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mstafa Hassan Sewefy

Assistant professor

Minia University

研究点 (1)

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