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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004889
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yokohama City University Medical Center, Gastroenterological center
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(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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005822

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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