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

ConditionsAchalasiaGERD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaria Sklodowska-Curie National Research Institute of Oncology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Lack of written consent for participation in the study

Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Patients who underwent POEM

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
36 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

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