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

May 13, 2022 updated by: Yanqing Li, Shandong University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients to be treated surgically for gastroesophageal reflux disease. Ineffective esophageal motility diagnosed by high resolution esophageal according to Chicago Classification version 4.0(defined as ≥ 70% of swallows with weak contraction (distal contraction interval (DCI) between 100mmHg/s/cm and less than 450 mmHg/s/cm) or ≥ 50% of swallows with failed peristalsis Performance.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IEM in patients with GERD with normal MRS contraction
Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests
Other: Follow-up visits
Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations
Other Names:
  • Questionnaire to assess symptoms and quality of life etc.
IEM in patients with GERD with abnormal MRS contraction
Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests
Other: Follow-up visits
Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations
Other Names:
  • Questionnaire to assess symptoms and quality of life etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery
Time Frame: 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.
2 year follow-up after anti-reflux surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of changes of post-anti-reflux surgery symptoms
Time Frame: 2 year follow-up after anti-reflux surgery
Reflux Symptom Questionnaire Assessment to assess the changes of symptoms
2 year follow-up after anti-reflux surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Study Chair: Yanqing Li, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Anticipated)

April 1, 2026

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-SDU-QILU-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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