UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004889 |
|---|---|
| Receipt number | R000005822 |
| Scientific Title | The randomized controled trial of the Penrose drain for the prevention of superficial surgical site infection in elective colorectal surgery. |
| Date of disclosure of the study information | 2011/01/20 |
| Last modified on | 2013/07/25 08:59:13 |
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Basic information
Public title
The randomized controled trial of the Penrose drain for the prevention of superficial surgical site infection in elective colorectal surgery.
Acronym
The randomized trial of the Penrose drain for the prevention of surgical site infection in colorectal surgery.
Scientific Title
The randomized controled trial of the Penrose drain for the prevention of superficial surgical site infection in elective colorectal surgery.
Scientific Title:Acronym
The randomized trial of the Penrose drain for the prevention of surgical site infection 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 evaluate the effectiveness of the Penrose drain for the prevention of the superficial surgical site infection in colorectal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of superficial surgical site infection in abdominal medial incision.
Key secondary outcomes
The rate of other complication (wound hemorrhage, seroma, wound dehiscence) in abdominal medial incision.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients without the Penrose drain
Interventions/Control_2
Patients with the Penrose drain: After suturing fascia, implant 6mm-PD with a slit to cover the whole length of wound.
Change the gauze to cover the top of the drain every day until drain is removed.
The 6-mm Penrose drain produced by Kaneka corporation should be used.
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
1)Patients undergoing elective surgery for colorectal cancer.
2)Patients aged over 20.
3)PS(ECOG)0-2
4)Patients with agreement by the document
Key exclusion criteria
1)Patients undergoing only stoma closure.
2)Patients undergoing emergency operation.
3)Patients undergoing single port laparotomy.
4)Patients judged to be inappropriate by doctor in charge.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujii Syoichi |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujii Syoichi |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama City University Medical Center, Gastroenterological center
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（神奈川県）
神奈川県立がんセンター（神奈川県）
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 20 | 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
| 2011 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 17 | Day |
Last modified on
| 2013 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005822
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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