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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037513
Receipt No. R000042768
Scientific Title Multicenter collaborative retrospective study of POEM for achalasia
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/28

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Basic information
Public title Multicenter collaborative retrospective study of POEM for achalasia
Acronym Multicenter collaborative retrospective study of POEM for achalasia
Scientific Title Multicenter collaborative retrospective study of POEM for achalasia
Scientific Title:Acronym Multicenter collaborative retrospective study of POEM for achalasia
Region
Japan

Condition
Condition Achalasia and esophageal motility disorders
Classification by specialty
Gastroenterology Gastrointestinal surgery Operative medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)To verify short-term and long term outcome of POEM
2)To identify the risk factor of GERD after POEM
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of GERD after POEM
The severity of GERD after POEM
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing POEM for esophageal achalasia at 12 facilities in Japan between September 2008 and March 2018
Key exclusion criteria None
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Haruhiro
Middle name
Last name Inoue
Organization Showa University Koto-Toyosu Hospital
Division name Digestive Diseases Center
Zip code 135-8577
Address Toyosu5-1-38, Koto-Ku, Tokyo, 135-8577, Japan
TEL 03-6204-6064
Email haruinoue777@yahoo.co.jp

Public contact
Name of contact person
1st name Hironari
Middle name
Last name Shiwaku
Organization Fukuoka University Faculty of Medicine
Division name Department of Gastroenterological Surgery
Zip code 8140180
Address 7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Homepage URL
Email hiro.shiwaku@gmail.com

Sponsor
Institute Digestive Diseases Center, Showa University Koto-Toyosu Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Gastroenterological Surgery Fukuoka University Faculty of Medicine
Address 7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
Tel 09095675463
Email hiro.shiwaku@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 2000
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 03 Month 06 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 07 Month 28 Day
Last modified on
2019 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042768

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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