Health Condition 1: null- Achalasia Cardia
Conditions
Interventions
Intervention1: Posterior approach in per oral endoscopic myotomy: Posterior approach ( 5 o clock incision) for per oral endoscopic myotomy
Control Intervention1: anterior approach in per oral endoscop
Sponsors
Asian Institute Of Gastroenterology
Eligibility
Inclusion criteria
Inclusion criteria: Achalasia cardia with Eckardt score >3 (0-12 scale achalasia) â??any type Treatment naïve or history of pneumatic balloon dilatation Willing and able to comply with the study procedures and provide written informed consent form to participate in the study
Exclusion criteria
Exclusion criteria: Previous surgery of the esophagus or stomach Active severe esophagitis Large lower esophageal diverticula Large > 3cm hiatal hernia Sigmoid esophagus Known gastroesophageal malignancy Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy Cirrhosis with portal hypertension, varices, and/or ascites Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) Acute gastrointestinal bleeding Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in the ekhardts score operative and post operative complicationsTimepoint: 1, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of GERD by pH impedanceTimepoint: 3months;change in barium column height on barium esophagogramTimepoint: Pre POEM, Post POEM and 1 month Post POEM;change in the quality of life before and after the POEM (by SF 32 questionnaire)Timepoint: Pre POEM and 1 month Post POEM;change in the symptoms of GERD by GERD - FSSG questionaireTimepoint: Pre POEM and 1 months Post POEM;changes in LES pressures by manometryTimepoint: 1 and 6 months;Total procedure time and Technical success rateTimepoint: during POEM | — |
Countries
India
Contacts
Public ContactDr Rahul P Talele
Asian Institute of Gastroenterology
Outcome results
None listed