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

Esophageal Motility Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380791
• Other study ID #: 2022-SDU-QILU-008
• Status: Recruiting
• Start date: April 22, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2022
• Source: Shandong University
• Contact: FeiXue Chen, MD
• Phone: 18560086108
• Email: qlxhkqz[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse

Intervention

Other:
• Follow-up visits
Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery	Using high resolution manometry to assess changes in oesophageal motility after anti-reflux surgery, compared to pre-surgery.	2 year follow-up after anti-reflux surgery
Secondary	Effect of changes of post-anti-reflux surgery symptoms	Reflux Symptom Questionnaire Assessment to assess the changes of symptoms	2 year follow-up after anti-reflux surgery