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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
POEM will be performed using a standardized technique.8 The patients will be prescribed a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) for two months after POEM. Consecutive patients who meet the inclusion and exclusion criteria will be followed up after 3 months. PPIs will be discontinued for at least 4 weeks prior to objective evaluation of GERD. Each patient returning after 3 months for follow up will undergo several follow up examinations, including GERD questionnaire scoring, Esophagogastroduodenoscopy, 24 hour pH impedance test. Presence of endoscopically visible esophagitis . Endoscopic findings such as anatomical location, dimensions of the mucosal breaks will be compared to general population with diagnosis of GERD who have endoscopically visible esophagitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assesment of reflux esophagitis in cases with esophageal motility | Active Comparator | Reflux esophagitis can be found in Endoscopy report. |
|
| Assesment of reflux esophagitis in cases without esophageal motility | Placebo Comparator | Reflux esophagitis can be found in cases in normal gastroesophageal reflux disease condition patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Per oral endoscopy myotomy (Per oral endoscopy myotomy) | Procedure | POEM is the procedure to reduce the symptoms of dysphagia, regurgitation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Assessment of the , esophageal acid exposure | esophageal acid exposure is a value indicates higher reflux can be calculated in ph impedence report | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Goud Mr Maragoni, M.Pharm, MBA | Contact | 04023378888 | 531 | rajeshgoud761@gmail.com |
| Zaheer Nabi Dr Mohammed, MBBS MD | Contact | 04023378888 | 102 | zaheernabi1978@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zaheer Nabi Dr Mohammed, MBBS MD | AIG Hospitals | Principal Investigator |
| Chinmay Dr Hegde, MBBS MD | AIG Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology Hospital | Recruiting | Hyderabad | Telangana | 500082 | India |
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| Endoscopy procedure | Procedure | Endoscopy procedure is required to rule out type of reflux disease |
|
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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