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临床试验/NCT06599489
NCT06599489尚未招募不适用

Sleeve Gastrectomy With Crural Repair With or Without Ligamentum Teres Wrapping in Obese Patients With Gastroesophageal Reflux Disease .Arandomized Controlled Trial

Hossam Mahmoud Ibrahim0 个研究点目标入组 100 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Weight loss and improvement of BMI

研究概览

简要总结

The aim of this study is to evaluate the efficacy Sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping for management of morbidly obese patients with concomitant reflux symptoms.

详细描述

All patients underwent a preoperative work-up including history and physical examination, routine laboratory investigations, ECG, chest radiography, pulmonary function tests, abdominal ultrasonography, and barium swallow, upper GIT endos¬copy, 24 hours PH monitoring, nutritional, and psychiat¬ric evaluation. Further exams and/or consultations were performed when indicated. The study design was a pro¬spective randomized controlled study that received ap¬proval from the ethics committee in relevant hospitals. All the patients gave an informed written consent All patients had a written informed consent of the two types laparoscopic procedures of obesity, Prophylactic anticoagulant medications will be given to all patients in the form of subcutaneous Clexane 0.5 unit/Kg/24. An Intensive care unit (ICU) bed will be reserved for all patients the night of operation with the decision of transfer left to the postoperative recovery assessment.

According to the patient selection, all patients will be divided into two groups as follows:

Group (A): Patients will do Laparoscopic sleeve gastrectomy with crural repair. Under a general anesthesia, the patient was placed in the split-leg position with the surgeon standing between the legs and the assistant on the left-hand side of the pa¬tient. A veress needle was used to create the pneumoperi-toneum. Three 12-mm trocars were inserted in the upper abdomen (one on the right, two on the left side) and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpel (Ethicon Endo-Surgery Inc., Cincinnati, OH) to get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural

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
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

  • Age 18-60 years.
  • Both sexes.
  • BMI ≥ 40 or ≥ 35 with co-morbidity.with reflux symptoms .
  • Failure of non-surgical treatment.
  • Patients with hiatus hernia .
  • Absence of endocrinal or psychological disorders.
  • Failure of non surgical treatment
  • Non sweat eaters
  • Patients with no previous upper GIT surgeries

排除标准

  • Presence of endocrinal or psychological disorders.
  • Morbidly obese patients with no reflux symptoms
  • sweat eaters
  • Patients with barrett,s oesophagus ,
  • Patient with bad general condition

结局指标

主要结局

Weight loss and improvement of BMI

时间窗: 6 momths

BMI from above 35 kg/m2 to less,than 30. kg /m2to be less than 35 kg /m2

Reflux symptoms

时间窗: 6 months

Improvement of all symptoms of reflux disease

次要结局

未报告次要终点

研究者

发起方
Hossam Mahmoud Ibrahim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hossam Mahmoud Ibrahim

Assistant lecturer at general surgery department

Assiut University

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