UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007058
Receipt number 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 13:46:48

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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 or person

Institute

Yokohama city University, Gastroenterological surgery

Institute

Department

Personal name



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

Value
https://center6.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