About this trial
Outcome after treatment of achalasia is usually assessed by the Eckardt score (ES). The timed barium esophagogram (TBE) is used to objectively assess esophageal clearance after treatment. High-resolution manometry with impedancemetry (HRiM) provides information on esophageal clearance of liquids in addition to motility parameters. The aim of this study was to compare esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.
Disqualifiers
Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.
Trial population
a single cohort of all patients with achalasia and treated by POEM at Bordeaux University Hospital and having performed HRiM and TBE in routine care
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
esophageal clearance
Difference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months
Secondary outcomes
Efficacy : score of Eckardt
Evaluation of Eckardt score at 3 months and 12 months post-POEM . Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12.
Efficacy : esophageal clearance
Evaluation of esophageal clearance at 3 months post-POEM .
Quality of life : Score QLQ-SF36
Self-questionnaire in 36 items evaluating the quality of life. The SF-36 questionnaire is made up of 36 questions which concern the last four weeks, divided into 8 dimensions (Physical activity / Life and relationships with others / Physical pain / Perceived health / Vitality / Limitations due to psychological state / Limitations due to physical state / Mental health).
Quality of life : QLQ-OES24
The QLQ-OES24 consists of 24 items assessing dysphagia, deglutition, abdominal/GI symptoms, eating difficulties, pain, emotional problems relating to esophageal cancer and to side effects of chemotherapy/radiotherapy.
Sponsors and contacts
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