An observational study in Achalasia and GERD, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-18.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Observational
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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.
143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's planned enrollment of 100 is close to the median of 111 across 41 observational studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 64 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM)
Time frame: 36 Months
Started Jun 2021 (actual). Primary completion is estimated for Jun 2024, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
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Maria Sklodowska-Curie National Research Institute of Oncology