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NCT Number: NCT05080634

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

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.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders GERD Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 36 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandra Budnicka-Borkowicz, MD

CONTACT

[email protected]

(+48) 791000890

Anna Chaber-Ciopińska, PhD

CONTACT

[email protected]

(+48) 225463044

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Oct 18, 2021
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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