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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034955
Receipt No. R000039857
Scientific Title Dementia in elderly patients undergoing early cholecystectomy for acute cholecystitis
Date of disclosure of the study information 2018/11/21
Last modified on 2019/07/02

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Basic information
Public title Dementia in elderly patients undergoing early cholecystectomy for acute cholecystitis
Acronym Dementia in elderly patients with acute cholecystitis
Scientific Title Dementia in elderly patients undergoing early cholecystectomy for acute cholecystitis
Scientific Title:Acronym Dementia in elderly patients with acute cholecystitis
Region
Japan

Condition
Condition Acute cholecystitis
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the association between dementia and outcomes after early cholecystectomy for acute cholecystitis in elderly patients

To evaluate the safety of early cholecystectomy for elderly patients with acute cholecystitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes complication rates
the length of postoperative hospital stay
routine discharge rates
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
85 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with AC over 85 years of age who underwent early cholecystectomy at Aizawa Hospital from January 2005 to March 2018
Key exclusion criteria None
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Nishida
Organization Aizawa Hospital
Division name Department of Surgery
Zip code
Address 2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
TEL 0263-33-8600
Email yasunori.198129@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Nishida
Organization Aizawa Hospital
Division name Department of Surgery
Zip code
Address 2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
TEL 0263-33-8600
Homepage URL
Email yasunori.198129@gmail.com

Sponsor
Institute Aizawa Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 11 Month 21 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 Completed
Date of protocol fixation
2018 Year 08 Month 30 Day
Date of IRB
2018 Year 08 Month 30 Day
Anticipated trial start date
2018 Year 08 Month 30 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information observational study
retrospective study

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039857

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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