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临床试验/NCT04834323
NCT04834323已完成不适用

Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy; A Randomized Control Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年12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
84
试验地点
2
主要终点
Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of gastric leakage .

研究概览

简要总结

This study included patients who were admitted to investigator's center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation.

详细描述

Laparoscopic sleeve gastrectomy is one of weight loss operations and widely performed all over the world . although its widely performed ,it has serious complications like leakage and bleeding . The proposed etiology behind leakage after laparoscopic sleeve gastrectomy may be the axial rotation of the stomach owing to loss of abdominal ligament fixation along the greater curvature of the stomach . The mechanism of increased intra-gastric pressure due to axial gastric rotation may put a lot of stress on the staple lines with increased incidence of leakage. Other complications may occur such as vomiting, food intolerance or persistent reflux.

Objectives:

To assess the effect of distal mesogastric fixation after laparoscopic sleeve gastrectomy to minimize gastric axial rotation and subsequent leakage and other related complications.

Patients and methods:

investigators included all patients who were subjected to laparoscopic sleeve gastrectomy at investigators' center between December 2019 to December 2020. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

no masking

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

  • Patients who had no contraindication for laparoscopic surgery.
  • patients with good general condition with American society of anesthesiology (ASA) I & II.
  • patients with body mass index above 35 were included.

排除标准

  • 1 - patients who had bad general condition (ASA ≥3). 2- patients with gastro esophageal reflux or hiatal hernia.

结局指标

主要结局

Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of gastric leakage .

时间窗: Within one week after the operation

Percentage of patients developed gastric leakage after the operation

Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of Axial gastric rotation.

时间窗: Within one week after the operation

Incidence of Axial gastric rotation after the operation

次要结局

  • Quality of life after distal mesogasric fixation after laparoscopic sleeve gastrectomy(Within one month after the operation)

研究者

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

Said Mohamed Said Abdou Negm

lecturer of general surgery

Zagazig University

研究点 (2)

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