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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028076
Receipt No. R000031951
Scientific Title Evaluation of postoperative pain relief in living liver donors
Date of disclosure of the study information 2017/07/10
Last modified on 2017/07/05

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Basic information
Public title Evaluation of postoperative pain relief in living liver donors
Acronym Evaluation of postoperative pain relief in living liver donors
Scientific Title Evaluation of postoperative pain relief in living liver donors
Scientific Title:Acronym Evaluation of postoperative pain relief in living liver donors
Region
Japan

Condition
Condition living liver donor
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 donor's safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes effectiveness of postoperative pain management
pain degree
side effect
improvement of ADL
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 living liver donor
patients who obtained the comprehensive informed concent
Key exclusion criteria Patient who underwent additional surgery within seven days after hepatectomy
Concent has been revoked
Inappropriate patient for this research
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Yamamoto
Organization Kumamoto University
Division name Anesthesiology
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto-shi, Kumamoto
TEL 096-373-5275
Email yamyam@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuri Tsukano
Organization Kumamoto University Hospital
Division name Anesthesiology
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto-shi, Kumamoto
TEL 096-373-5275
Homepage URL
Email yuri-tsuka@kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization none
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
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
2017 Year 07 Month 10 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
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of postoperative course on patients who underwent hepatectomy for living liver donation between January 2013 and June 2017 at Kumamoto University Hospital, retrospectively.

Management information
Registered date
2017 Year 07 Month 05 Day
Last modified on
2017 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031951

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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