UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011602 |
|---|---|
| Receipt number | R000013572 |
| Scientific Title | Prospective study of the relationship between preoperative status and postoperative complications in hepato-biliary-pancreatic surgery |
| Date of disclosure of the study information | 2013/08/30 |
| Last modified on | 2015/08/30 09:46:14 |
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Basic information
Public title
Prospective study of the relationship between preoperative status and postoperative complications in hepato-biliary-pancreatic surgery
Acronym
Prospective study of the relationship between preoperative status and postoperative complications in hepato-biliary-pancreatic surgery
Scientific Title
Prospective study of the relationship between preoperative status and postoperative complications in hepato-biliary-pancreatic surgery
Scientific Title:Acronym
Prospective study of the relationship between preoperative status and postoperative complications in hepato-biliary-pancreatic surgery
Region
| Japan |
Condition
Condition
surgery for hepato-biliary-pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate preoperative predictors which influence postoperative clinical outcomes in hepato-biliary-pancreatic surgery.
Basic objectives2
Others
Basic objectives -Others
This study is a prospective cohort study to identify the relationship between preoperative status and postoperative complications in hepato-biliary-pancreatic surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical outcomes(length of postoperative hospital stay, complications)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who receive hepato-biliary-pancreatic surgery.
Key exclusion criteria
patients under 20 years old
patients we judge to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Yoshida |
Organization
Okayama University Hospital
Division name
Department of Hepato-biliary-pancreatic Surgery
Zip code
Address
2-5-1, Shikata cho, Kita ku, Okayama city
TEL
086-235-7257
ryuichi-yoshida@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosei Takagi |
Organization
Okayama University Hospital
Division name
Department of Hepato-biliary-pancreatic Surgery
Zip code
Address
2-5-1, Shikata cho, Kita ku, Okayama city
TEL
086-235-7257
Homepage URL
kosei0913@hotmail.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
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
| 2013 | Year | 08 | Month | 30 | 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
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
The purpose of this study is to investigate useful preoperative predictors which influence postoperative clinical outcomes in hepato-biliary-pancreatic surgery.
Management information
Registered date
| 2013 | Year | 08 | Month | 30 | Day |
Last modified on
| 2015 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013572
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
