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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ACTIVE_NOT_RECRUITING
NA
55 participants
INTERVENTIONAL
2019-04-15
2027-12-31
Brief Summary
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Detailed Description
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Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score).
At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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total division of the muscle layer
POEM- total division of the circular muscle layer into the gastroesophageal junction
POEM
Peroral endoscopic myotomy
partial division of the muscle layer
POEM - partial division of the circular muscle layer into the gastroesophageal junction
POEM
Peroral endoscopic myotomy
Interventions
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POEM
Peroral endoscopic myotomy
Eligibility Criteria
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Inclusion Criteria
* the patient should understand the nature and the purpose of the study and give informed consent
Exclusion Criteria
* inability to understand the contents of or follow the protocol
* other pathology as an explanation for the obstruction of the esophageal transition
18 Years
70 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Anders Thorell
Professor
Principal Investigators
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Anders Thorell, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institutet, Ersta Hospital
Stockholm, Region Stockholm, Sweden
Karolinska Institutet
Stockholm, Stockholm County Council, Sweden
Countries
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Other Identifiers
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2017/1630-31
Identifier Type: -
Identifier Source: org_study_id
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