Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy

NCT05080634 | Recruiting

• 1 other identifier: 22042020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.

Conditions

Achalasia; GERD

Keywords

Peroral endoscopic myotomy; High-resolution esophageal manometry

Outcome Measures

Primary Outcomes (1)

• The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM)

  36 Months

Interventions

Patients who underwent POEM OTHER

chalasia patients were recruited from a single center. The pre- and postoperative assessments included Eckardt scores, GerdQ questionnaire, high-resolution esophageal manometry, esophagogastroscopy and pH monitoring.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients treated at a single center who had a complete GERD evaluation after POEM will be included in the study. Demographics, preoperative and follow-up data, results of functional studies and procedural data will be collected and analyzed.

You may qualify if:

• Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF)
• Achalasia patients who underwent POEM

You may not qualify if:

• Lack of written consent for participation in the study
• Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anna Chaber-Ciopińska, PhD

  The Maria Sklodowska-Curie National Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Chaber-Ciopińska, PhD

CONTACT

(+48) 225463044; annachaber@op.pl

Aleksandra Budnicka-Borkowicz, MD

CONTACT

(+48) 791000890; aleksandra.budnicka-borkowicz@coi.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

PL (1)