Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
NCT ID: NCT06870630
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
158 participants
INTERVENTIONAL
2023-11-29
2025-07-30
Brief Summary
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Detailed Description
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• To study the incidence of true reflux on 24 hour pH analysis with manual study.
Secondary objective -
* To analyse treatment success which is defined as Eckdart score \< 3 at follow up assessment ( 3rd month)
* To analyse the recovery of peristalsis after POEM using High resolution manometry
* To study total procedure time , intra operative adverse effects and duration of hospital stay.
* Severity of oesophagitis
* Presence of GERD symptoms based on GERD questionnaire \& Quality of life questionaire post procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Per oral endoscopy myotomy for standard myotomy
Standard myotomy is muscle fibers cutting in esophagus more than 7 cms
Per oral endoscopy myotomy
Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.
Per oral endoscopy myotomy for esophago gastric junction myotomy
Myotomy is muscle fibers cutting in esophagus less than 3 cms.
Per oral endoscopy myotomy
Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.
Interventions
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Per oral endoscopy myotomy
Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
Exclusion Criteria
* Patients with previous endoscopic or surgical treatment for achalasia
18 Years
75 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Mohan Ramchandani
Director
Principal Investigators
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Mohan Dr Ramchandani, MBBS MD
Role: STUDY_DIRECTOR
AIG Hospitals
Zaheer Dr Nabi, MBBS MD
Role: PRINCIPAL_INVESTIGATOR
AIG Hospitals
Pradev Dr Inovolu, MBBS MD
Role: PRINCIPAL_INVESTIGATOR
AIG Hospitals
Locations
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Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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POEMUSM
Identifier Type: -
Identifier Source: org_study_id
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