UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034955 |
|---|---|
| Receipt number | 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 06:12:06 |
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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
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
yasunori.198129@gmail.com
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039857
