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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004967
Receipt No. R000005909
Scientific Title Effect of peritoneal lavage in elective colorectal surgery: a randomised trial
Date of disclosure of the study information 2011/01/27
Last modified on 2013/04/02

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Basic information
Public title Effect of peritoneal lavage in elective colorectal surgery: a randomised trial
Acronym peritoneal lavage in colorectal surgery
Scientific Title Effect of peritoneal lavage in elective colorectal surgery: a randomised trial
Scientific Title:Acronym peritoneal lavage in colorectal surgery
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to clarify the effectiveness of peritoneal lavage to prevent surgical site infection in elective colorectal surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes rate of SSI
Key secondary outcomes post operative course; rate of complication, development of fever, dulation of hospital stay)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 perform the paritoneal lavage with 3,000ml 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 colorectal cancer patient
electove surgery
Surgical wound classification: Class II
Key exclusion criteria Surgical wound classification: Class III, IV
surgery with colostomy
exsictance of peritoneal dissemination
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Ota
Organization Yokohama City University Hospital
Division name Yokohama City University, Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuyoshi Ota
Organization Yokohama City University Hospital
Division name Yokohama City University, Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email

Sponsor
Institute Yokohama City University, Gastroenterological surgery
Institute
Department

Funding Source
Organization None
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 横浜市立大学附属市民総合医療センター
横浜市立大学附属病院
 Yokohama City University Medical Center (Kanagawa)
Yokohama City University Hospital(kanagawa)
(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 27 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
2008 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 27 Day
Last modified on
2013 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005909

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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