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Comparison of different types of incision for Entry Into The Submucosal Space During Per Oral Endoscopic Myotomy For Esophageal Motility Disorders

A Randomized Controlled Trial To Compare Transverse Versus Longitudinal Incision For Entry Into The Submucosal Space During Per Oral Endoscopic Myotomy For Esophageal Motility Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035829
Enrollment
60
Registered
2021-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K220- Achalasia of cardia Health Condition 2: K224- Dyskinesia of esophagus

Interventions

Intervention1: Longitudinal incision for entry in to submucosal space: Endoscopist who has performed more than 50 cases will perform the POEM procedure. Patients who present with dysphagia, non-cardia

Sponsors

Post graduate institute of medical education and research chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of Esophageal Motility Disorders ( achalasia cardia type I,II and III, non achalasia cardia- jack hammer esophagus, diffuse esophageal spasm) on the basis of high resolution manometry (HRM)

Exclusion criteria

Exclusion criteria: -Informed consent not available -Contraindication to general anaesthesia -Coagulopathy

Design outcomes

Primary

MeasureTime frame
Success rate of entry into the submucosal space by transverse versus longitudinal incisionTimepoint: At baseline

Secondary

MeasureTime frame
(i) Complication rate (ii) Ease of completing tunnel and myotomy (iii) Time taken for incision (iv) Need for taking separate incision due to failure of the primary incision (v) Ease of closure of the mucosal incision (vi) Chance of extension of the mucosal incision while doing tunneling Timepoint: At baseline

Countries

India

Contacts

Public ContactJayendra Shukla

Post graduate institute of medical education and research Chandigarh

hmandavdhare760@gmail.com9592814877

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026