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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011602
Receipt No. 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

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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
Email 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
Email kosei0913@hotmail.co.jp

Sponsor
Institute Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013572

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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