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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047631
Receipt No. R000054307
Scientific Title Japanese nationwide survey of acute acalculous cholecystitis
Date of disclosure of the study information 2022/05/16
Last modified on 2022/04/30

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Basic information
Public title Japanese nationwide survey of acute acalculous cholecystitis in the era of Tokyo guideline
Acronym Japanese nationwide survey of acute acalculous cholecystitis in the era of Tokyo guideline
Scientific Title Japanese nationwide survey of acute acalculous cholecystitis
Scientific Title:Acronym Japanese nationwide survey of acute acalculous cholecystitis
Region
Japan

Condition
Condition Patients who underwent treatment for acute acalculous cholecystitis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the incidence, background factors, therapeutic modality, and outcomes of AAC in Japan
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Age, sex, comorbidity, American Society of Anesthesiologists physical status, Charlson comorbidity index, severity of acute cholecystitis, treatment, infectious complications, hospital stay, readmission, mortality
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 who underwent treatment for acute acalculous cholecystitis between January 2018 and December 2020
Key exclusion criteria None
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Morikawa
Organization Tohoku University Hospital
Division name Department of Surgery
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7205
Email t_morikawa@surg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Takanori
Middle name
Last name Morikawa
Organization Tohoku University Hospital
Division name Department of Surgery
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7205
Homepage URL
Email t_morikawa@surg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospita, Department of Surgery
Institute
Department

Funding Source
Organization Japanese Society for Abdominal Emergency Medicine
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 Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel 0227178007
Email med-kenkyo@grp.tohoku.ac.pj

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
2022 Year 05 Month 16 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
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 Enrolling by invitation
Date of protocol fixation
2021 Year 11 Month 29 Day
Date of IRB
2021 Year 12 Month 21 Day
Anticipated trial start date
2022 Year 05 Month 16 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This observational study examines not only the frequency of acalculous acute cholecystitis in Japan, but also the correlation between prognosis and background factors, severity of cholecystitis, and treatment.

Management information
Registered date
2022 Year 04 Month 30 Day
Last modified on
2022 Year 04 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054307

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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