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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011096
Receipt No. R000012994
Scientific Title The study of the preventin of gastric stasis after left hepatectomy
Date of disclosure of the study information 2013/08/01
Last modified on 2019/06/11

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Basic information
Public title The study of the preventin of gastric stasis after left hepatectomy
Acronym The study of the preventin of gastric stasis after left hepatectomy
Scientific Title The study of the preventin of gastric stasis after left hepatectomy
Scientific Title:Acronym The study of the preventin of gastric stasis after left hepatectomy
Region
Japan

Condition
Condition live tumor
living liver donor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effective prevention of gastric stasis after left hepatectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of gastric stasis after left hepatectomy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Omentum patching
Interventions/Control_2 Putting Seprafilm
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who undergo left hepatectomy
Key exclusion criteria The patients who prefiously underwent abdominal surgery
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhisa Takatsuki
Organization Nagasaki University
Division name Department of Surgery
Zip code
Address 1-7-1Sakamoto, Nagasaki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagasaki University
Division name Department of Surgery
Zip code
Address
TEL 095-819-7316
Homepage URL
Email

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Departmento of Surgery, Nagasaki Univ.
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
2013 Year 08 Month 01 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 07 Month 01 Day
Date of IRB
2013 Year 07 Month 01 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 02 Day
Last modified on
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012994

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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