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临床试验/NCT05380791
NCT05380791招募中不适用

Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After Anti-reflux Surgery in Patients With Gastroesophageal Reflux Disease

Shandong University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery

研究概览

简要总结

rapid swallow (MRS) can assess the contractile reserve capacity of the oesophageal body and identify and diagnose oesophageal motility disorders, but the impact of preoperative oesophageal reserve capacity on postoperative symptoms and motility in patients with GERD remains unclear. The aim of this study was to assess the effect of pre-operative oesophageal reserve capacity on post-reflux symptoms and motility in patients with GERD by using a high-resolution oesophageal manometry-based provocation test, MRS, to track pre-operative ineffective oesophageal motility (IEM).

详细描述

Lower oesophageal sphincter relaxation is an important cause of GERD and ineffective oesophageal motility may be associated with GERD, but the mechanism of oesophageal corporal motility disorders is unclear. High-resolution manometry (HRM) has shown to be more accurate than conventional manometry in assessing oesophageal motility, and can provide guidance for GERD surgery. The aim was to conduct a cohort study to investigate the yu'h of patients with preoperative esophageal motility disorders with or without esophageal reserve, based on the assessment of esophageal motility by high-resolution esophageal manometry to follow up changes in esophageal motility and symptoms in patients after anti-reflux surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age over 18 years old
  • Patients to be treated surgically for gastroesophageal reflux disease
  • Ineffective esophageal motility diagnosed by high resolution esophageal manometry according to Chicago Classification version 4.0
  • Obtaining Informed Consent

排除标准

  • Previous other upper gastrointestinal surgery
  • Pregnant women and other people with contraindications to surgery and tests
  • Other specifically defined esophageal motility disorders, such as nutcracker esophagus

结局指标

主要结局

Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery

时间窗: 2 year follow-up after anti-reflux surgery

Using high resolution manometry to assess changes in oesophageal motility after anti-reflux surgery, compared to pre-surgery.

次要结局

  • Effect of changes of post-anti-reflux surgery symptoms(2 year follow-up after anti-reflux surgery)

研究者

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

Yanqing Li

Vice-President

Shandong University

研究点 (1)

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