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Prospective study to evaluate the clinical outcome of POEM combined with endoscopic anti-reflux surgery.

Prospective study to evaluate the clinical outcome of POEM combined with endoscopic anti-reflux surgery. - Endoscopic anti-reflux surgery and POEM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028567
Enrollment
100
Registered
2017-08-08
Start date
2017-08-10
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

esophageal achalasia

Interventions

conventional POEM adding endoscopic anti-reflux surgery

Sponsors

Showa University Koto Toyosu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are planning to undergo POEM surgery, and who can recieve informed consent document.

Exclusion criteria

Exclusion criteria: 1: severe achalasia (ex. sigmoid type) 2: non-achalasia 3: taking anti-thrombotic agents 4: who has severe complications(Diabetes, Heart disease, Strokes, Neurological disorder, Psychosis, etc.) 5: a history of complications with anesthesia 6: pregnant and breast-feeding 7: who cannot withdraw PPI 8: consent can not be obtained 9: other inappropriate cases

Design outcomes

Primary

MeasureTime frame
1: The reslut of multichannel intraluminal impedance pH monitoring(MII-pH) 2: endoscopic findings 3: symptoms 4: whether the patients needs PPI or not in 2 months later and 1 year later from the surgery. 5: QERD-Q score and F-scale

Secondary

MeasureTime frame
1: The clinical outcome of POEM(Eckardt score, esophageal manometry, esophagography) 2: Adverse event due to surgery

Countries

Japan

Contacts

Public ContactAkiko Toshimori

Showa University Koto Toyosu Hospital Digestive disease center

akikoueno@med.showa-u.ac.jp03-6204-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026