Clinical trial NCT05380791: Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After ARS in Patients With GERD
Official title: Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After Anti-reflux Surgery in Patients With Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Motility Disorders
Keywords: contraction reserve
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery
timeFrame: 2 year follow-up after anti-reflux surgery
Secondary outcomes:
measure: Effect of changes of post-anti-reflux surgery symptoms
timeFrame: 2 year follow-up after anti-reflux surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, phD
role: STUDY_CHAIR
References: