Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After ARS in Patients With GERD

Recruiting

• Conditions: Esophageal Motility Disorders
• Interventions: Other: Follow-up visits

• Registration Number: NCT05380791
• Lead Sponsor: Shandong University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-04-21
• Study Start: 2022-04-22
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-13
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Primary Completion: 2026-04-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IEM in patients with GERD with normal MRS contraction	Follow-up visits	Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests
IEM in patients with GERD with abnormal MRS contraction	Follow-up visits	Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests

Primary Outcome Measures

Name	Time	Method
Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Effect of changes of post-anti-reflux surgery symptoms	2 year follow-up after anti-reflux surgery	Reflux Symptom Questionnaire Assessment to assess the changes of symptoms

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China