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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007058
Receipt No. R000008318
Scientific Title Effect of peritoneal lavege in liver surgery: a randomised trial
Date of disclosure of the study information 2012/01/16
Last modified on 2015/02/16

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Basic information
Public title Effect of peritoneal lavege in liver surgery: a randomised trial
Acronym Peritoneal lavage in liver surgery
Scientific Title Effect of peritoneal lavege in liver surgery: a randomised trial
Scientific Title:Acronym Peritoneal lavage in liver surgery
Region
Japan

Condition
Condition elective liver surgery
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness of peritoneal lavage to prevent surgical
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of SSI
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Perform the peritoneal lavage with 3000ml of warm saline
Interventions/Control_2 not perform the peritoneal lavage
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 elective liver surgery
surgical wound classification : class II
Key exclusion criteria surgical wound classification : class III of IV
existence of peritoneal dissemination
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniya Tanaka
Organization Yokohama city University Hospital
Division name gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004, Japan
TEL 045-787-2650
Email t.kumamoto@k5.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Kumamoto
Organization Yokohama city university Hospital
Division name Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004, Japan
TEL 045-787-2650
Homepage URL
Email t.kumamoto@k5.dion.ne.jp

Sponsor
Institute Yokohama city University, Gastroenterological surgery
Institute
Department

Funding Source
Organization Yokohama city University, Gastroenterological surgery
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
2012 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results 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
2012 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 11 Month 01 Day
Date analysis concluded
2014 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 12 Day
Last modified on
2015 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008318

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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