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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010302
Receipt No. R000007308
Scientific Title Analysis of a new liver retraction for laparoscopic surgery
Date of disclosure of the study information 2013/03/22
Last modified on 2013/03/22

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Basic information
Public title Analysis of a new liver retraction for laparoscopic surgery
Acronym liver retractor for laparoscopic surgery
Scientific Title Analysis of a new liver retraction for laparoscopic surgery
Scientific Title:Acronym liver retractor for laparoscopic surgery
Region
Japan

Condition
Condition gastric tumor
Classification by specialty
Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It is important for laparoscopic gastrectomy to retract the lateral segment of the liver to achieve the precise surgery and some of the liver retractor often leads transient liver dysfunction after surgery. For an easier and safer procedure, we invented a new liver retractor and induced it to clinical application.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood was collected from the patients on day 1, 3 and 7 after surgery, examining the abnormal liver function.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Blood was collected from the patients on day 1, 3 and 7 after surgery, examining the abnormal liver function.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria over 20 years, male or female, those who had all agreed to participate after oral and written information.

Key exclusion criteria The patients who were diagnosed as not eligible for this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University Graduate School of Medicine
Division name Department of Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chu-ou-ku, Chiba, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University Graduate School of Medicine
Division name Department of Frontier Surgery
Zip code
Address
TEL 043-226-2110
Homepage URL
Email

Sponsor
Institute Frontier Surgery, Chiba University graduate School of Medicine
Institute
Department

Funding Source
Organization Frontier Surgery, Chiba University graduate School of Medicine
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 03 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 08 Day
Last follow-up date
2010 Year 12 Month 31 Day
Date of closure to data entry
2011 Year 01 Month 10 Day
Date trial data considered complete
2011 Year 01 Month 11 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 22 Day
Last modified on
2013 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007308

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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