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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05080634
Enrollment
100
Registered
2021-10-18
Start date
2021-06-01
Completion date
2026-09-01
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, GERD

Keywords

Peroral endoscopic myotomy, High-resolution esophageal manometry

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.

Interventions

OTHERPatients who underwent POEM

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.

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF) 2. Achalasia patients who underwent POEM

Exclusion criteria

1. Lack of written consent for participation in the study 2. Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry

Design outcomes

Primary

MeasureTime frame
The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM)36 Months

Countries

Poland

Contacts

Primary ContactAnna Chaber-Ciopińska, PhD
annachaber@op.pl(+48) 225463044
Backup ContactAleksandra Budnicka-Borkowicz, MD
aleksandra.budnicka-borkowicz@coi.pl(+48) 791000890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026