Comparison of anterior versus posterior approch for myotomy in Per Oral Endoscopic Myotomy (POEM) in treatment of Achalasia Cardia

Not Applicable

• Conditions: Health Condition 1: null- Achalasia Cardia

• Registration Number: CTRI/2016/05/006949
• Lead Sponsor: Asian Institute Of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in the ekhardts score <br/ ><br>operative and post operative complicationsTimepoint: 1, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
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