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This observational study will be conducted among 43 patients of both sexes in each group Study participants will be of the age more than 18 years
First evaluation at 1-month: based on Symptoms
• Second evaluation: at 6 months by
• The primary outcome of the study is the incidence of significant reflux esophagitis (≥grade B) in cases with standard and extended gastric myotomies at 6 months after POEM
Secondary outcomes:
Eligibility:
Eligible cases with idiopathic achalasia (type I and II) will be enrolled in the study and randomized (1:1 ratio) in two groups according to the length of gastric myotomies
INCLUSION CRITERIA :
Exclusion criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myotomy length | Extended myotomy >2.5cm |
| |
| MYOTOMY LENGTH | Extended myotomy>3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Per Oral Endoscopy Myotomy (POEM) | Device | POEM is a form of natural orifice transluminal endoscopic surgery that is completed by creating a submucosal tunnel in the lower part of esophagus to reach the inner circular muscle bundles of the LES to perform myotomy, while preserving the outer longitudinal muscle bundles. The result is decreased resting pressure of the LES, facilitating the passage of ingested material. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux | incidence of reflux esophagitis >grade B in cases with standard and extended gastric myotomies after POEM | 6 months |
| Ph metry test for gastroesophageal reflux | Significant esophageal acid exposure(> 6%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of Gastro esophageal reflux disease | Health related quality of life questionaires or scores in numericals | 6 months |
| High resolution manometry parameters(LES pressures and IRP) | lower esophageal sphincter pressure will be assesed by mmhg, integrated resting pressure in mmhg units |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible cases with idiopathic achalasia(type I & II) will be enrolled in the study
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| Name | Affiliation | Role |
|---|---|---|
| Zaheer Nabi, MBBS MD DNB | ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology /Aig Hospitals | Hyderabad | Telangana | 500082 | India |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| 6 months |
| D004066 | Digestive System Diseases |