A randomized controlled trial to compare short segment versus long segment myotomy during Per Oral Endoscopic Myotomy for Achalasia Cardia

Not Applicable

• Conditions: Health Condition 1: K220- Achalasia of cardia

• Registration Number: CTRI/2020/01/022933
• Lead Sponsor: AIIMS New Delhi

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Achalasia cardia (type I and II)

2. Eckardt score >3

3. Patient willing to undergo scheduled follow-up after POEM.

4. ASA class I or II

Exclusion Criteria

1. Prior surgical treatment of achalasia (previous endoscopic balloon dilation or botox injection will not be taken as exclusion criteria)

2. Pregnancy or nursing mothers

3. Severe co-morbid condition such as congestive heart failure, renal failure, or respiratory failure

4. Coagulopathy with INR >1.6 or platelet count <50000/cmm

5. Cirrhosis with or without portal hypertension with or without esophageal varices

6. Secondary achalasia

7. Sigmoid esophagus: A sigmoid esophagus is tortuous (diameter > 6 cm) with axis deviation. Sigmoid achalasia is further classified into two types on the basis of computed tomography (CT)â??(i) Sigmoid type 1 (S1): the esophagus is significantly dilated and tortuous with single lumen only, (ii) Sigmoid type 2 (S2): the esophagus is very dilated and tortuous with double lumen on single CT slice

8. Epiphrenic esophageal diverticulum: Epiphrenic diverticulum are pulsion type diverticulum located in the distal esophagus. They are pseudodiverticulum and lack muscle layer. They are commonly associated with motility disorders, including achalasia cardia. Any epiphrenic diverticulum, which is large enough, and likely to require modification in the posterior myotomy, will be excluded from the study.

9. Any contra-indications for endoscopy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of treatment success at 3 months and 1 year between short segment myotomy vs long segment myotomy.Treatment success will be defined based on Eckardtâ??s score. A score of 3 or less after the procedure will be defined as clinical success of the procedure.Timepoint: 3 months and 1 year