UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004967 |
|---|---|
| Receipt number | 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 15:34:19 |
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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
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
Sponsor or person
Institute
Yokohama City University, Gastroenterological surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005909
