Health Condition 1: K220- Achalasia of cardia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 2. Signed informed consent 3. Patient accepts to undergo scheduled follow-up after POEM 4. Eckardt score > 3 5. ASA I-II-III
Exclusion criteria
Exclusion criteria: 1. Prior surgical treatment of achalasia 2. Pregnancy or nursing 3. Type 3 I achalasia cardia or any other esophageal motility disorder 4. Active severe esophagitis,Eosinophilic esophagitis or Barrett Esophagus 5. large lower Esophageal diverticula, Esophageal stricture 6. Large > 3cm hiatal hernia 7. Sigmoid esophagus 9. known Gastro Esophageal malignancy Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy 10. Current alcohol or drug addiction. 11. Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in 12. the opinion of the investigator make the subject a poor candidate for this study. 13. Severe congenital or acquired coagulopathy or INR > 1.6 14. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Non-inferiority of a Short-POEM compared to a Long-POEMTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Basal Lower Esophageal Sphincter (LES) pressure 2. 4-second Integrated Relaxation Pressure (4sIRP) 3. Side effects and complications 4. Comparison of gastroesophageal Reflux disease (GERD) Rates 5. Operating time 6. Comparison of changes in Eckardt score 7. Change in barium column height on barium esophagogramTimepoint: 1 year | — |
Countries
India
Contacts
SGPGIMS,lucknow