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

NCT ID: NCT05380791

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-22

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Esophageal Motility Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IEM in patients with GERD with normal MRS contraction

Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests

Follow-up visits

Intervention Type OTHER

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

IEM in patients with GERD with abnormal MRS contraction

Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests

Follow-up visits

Intervention Type OTHER

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

Interventions

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Follow-up visits

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

Intervention Type OTHER

Other Intervention Names

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Questionnaire to assess symptoms and quality of life etc.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice-President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, phD

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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FeiXue Chen, MD

Role: CONTACT

18560086108

Yanqing Li, phD

Role: CONTACT

86-531-82169236

Facility Contacts

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Yanqing Li, PhD. MD.

Role: primary

18678827666

Other Identifiers

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2022-SDU-QILU-008

Identifier Type: -

Identifier Source: org_study_id

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