About this trial
Achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (LES), thought to be due to damage to the myenteric plexus with an unknown cause.1 Per-oral endoscopic myotomy (POEM) is an established endoscopic treatment modality for achalasia. Leading gastrointestinal (GI) societies endorse POEM as one of the primary treatment option for achalasia.This study aims to characterize and compare the morphological characteristics of reflux related erosions after the POEM procedures versus those in cases without esophageal motility disorders.
Data collection
1. Demographic characteristics: Age, gender, type of achalasia 2. Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure 3. Comorbidities 4. Medications 5. Eckardt score: before procedure and 3-months after Procedure 6. POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay 7. Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18y,
confirmed diagnosis of Achalasia,
No contraindication to POEM,
erosive esophagitis on endoscopy
Disqualifiers
Non-esophageal esophageal motility disorders,
Treatment other than POEM,
current PPI use before assessment for GERD
Trial design
Parallel
Treatments tested in this trial
Per oral endoscopy myotomy (Per oral endoscopy myotomy)
Procedure/SurgeryPOEM is the procedure to reduce the symptoms of dysphagia, regurgitation.
Endoscopy procedure
Procedure/SurgeryEndoscopy procedure is required to rule out type of reflux disease
Treatment groups
Trial outcomes
Primary outcomes
comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders
Reflux esophagitis can be calculated as grade B category (red colour scar found in esophagus mucosa) during endoscopy procedure
Assessment of the , esophageal acid exposure
esophageal acid exposure is a value indicates higher reflux can be calculated in ph impedence report
Sponsors and contacts
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