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

NCT ID: NCT05080634

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Achalasia GERD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Patients 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Chaber-Ciopińska, PhD

Role: PRINCIPAL_INVESTIGATOR

The Maria Sklodowska-Curie National Research Institute of Oncology

Locations

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Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Anna Chaber-Ciopińska, PhD

Role: CONTACT

(+48) 225463044

Aleksandra Budnicka-Borkowicz, MD

Role: CONTACT

(+48) 791000890

Facility Contacts

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Anna Chaber-Ciopińska, PhD

Role: primary

+48 225463044

Aleksandra Budnicka-Borkowicz, MD

Role: backup

+48 791000890

Other Identifiers

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22042020

Identifier Type: -

Identifier Source: org_study_id