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临床试验/NCT07349732
NCT07349732尚未招募不适用

Comparative Study Between Ligamentum Teres Cardiopexy and Gastric Bypass in Treatment of Post Sleeve Gastrectomy GERD

Andrew Mokbel0 个研究点目标入组 35 人开始时间: 2026年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35

研究概览

简要总结

The aim of this study is to evaluate the effectiveness and safety of surgical repair techniques with ligamentum teres cardiopexy on symptomatic relief of gastroesophageal reflux disease (GERD), recurrence rates of hiatus hernia, and overall patient quality of life following sleeve gastrectomy

详细描述

Laparoscopic sleeve gastrectomy (LSG) has become one of the most commonly performed bariatric procedures worldwide due to its effectiveness in achieving sustained weight loss and improving obesity-related comorbidities. However, it is increasingly recognized that LSG may lead to or exacerbate gastroesophageal reflux disease (GERD) and contribute to the development or worsening of hiatus hernia (HH). GERD incidence after LSG has been reported to range from 20% to 60%, making it a significant postoperative complication impacting patient quality of life. The underlying pathophysiology involves changes in gastroesophageal anatomy and physiology following the resection of the gastric fundus and alteration of the lower esophageal sphincter pressure, along with increased intragastric pressure due to the sleeve's tubular shape Changes after a sleeve gastrectomy

  1. Sectioning the gastric fundus leaves the upper esophagus open when the food passes and changes the angle of His from 36° to 51
  2. Damaging the sling fibers, cutting the noose that forms the LES, and promoting GERD
  3. Augmented intragastric pressure, confirmed by manometry, increases the gastroesophageal pressure gradient and reflux
  4. Herniation of the gastric tube into the thoracic cavity, disarming the associated gastro and esophagus-phrenic ligaments, leaving the pouch with a greater capacity to suffer from the pressures applied by the stomach and thorax, which may produce a hiatal hernia (HH)
  5. Vagal nerve injury
  6. Poor surgical technique leads to twisting, kinking, or strictures of the gastric tube.
  7. A dynamic pylorus When Surgery Is Considered

After SG, most patients with GERD are first managed with lifestyle changes and medical therapy (e.g. PPIs). Surgery or more invasive interventions are considered when:

  1. GERD symptoms are refractory despite maximal medical treatment.
  2. There are anatomical problems contributing to reflux, e.g. hiatal hernia, sleeve twist, stenosis, sleeve dilation, intrathoracic migration of the sleeve.
  3. There's also insufficient weight loss or weight regain (so revisional surgery may serve dual purposes).

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • patients who previously underwent laparoscopic sleeve gastrectomy
  • Adequate anatomy to perform the procedure For example, ability to mobilize adequate intra-abdominal esophagus (e.g. freeing 3-5 cm of esophagus into abdomen) and enough ligamentum teres tissue to wrap/fix
  • Patients experiencing GERD symptoms refractory to medical therapy (e.g., proton pump inhibitors more than 8 weeks )

排除标准

  • • Known esophageal motility disorders (achalasia, scleroderma).
  • Barrett's esophagus with high grade dysplasia
  • Presence of complications contraindicating the use of ligamentum teres For example, prior surgeries that compromised ligamentum teres, hepatic disease, malignancy near ligament region

研究者

发起方
Andrew Mokbel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Andrew Mokbel

director

Assiut University

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