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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004001
Receipt No. R000004812
Scientific Title Impact of Subcuticular Suture to prevent surgical site infection after elective colorectal surgery
Date of disclosure of the study information 2010/08/05
Last modified on 2014/02/21

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Basic information
Public title Impact of Subcuticular Suture to prevent surgical site infection after elective colorectal surgery
Acronym Subcuticular Suture against Infection: SSI study
Scientific Title Impact of Subcuticular Suture to prevent surgical site infection after elective colorectal surgery
Scientific Title:Acronym Subcuticular Suture against Infection: SSI study
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether subcuticular suture can prevent surgical site infection after 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 incisional surgical site infection
Key secondary outcomes wound complication rate
length of postoperative stay
wound closure time
aethesity
patient satisfaction

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 YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 group A: to close wound with stapler with 10mm interval
Interventions/Control_2 group B: to close wound with interupted subcuticular suture with 4-0 or 5-0 monofilament material
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; elective colorectal cancer surgery
2: performance status (ECOG): 0 or 1
3: age above 20 years old
4: major organ function is maintained
5: written informed consent
Key exclusion criteria 1: emergency surgery
2: other than cancer surgery
3: surgery for recurrent site
4: patient with active infection
5: pregnant women
6: patient with preoperative chemotherapy or chemoratiotherapy
7: poor controlled diabetes mellitus
8: major organ dysfunction
9: patient with stoma
10: without written informed consent
11: physician`s judgement
Target sample size 1240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Moriya
Organization National Cancer Center Hospital
Division name Colorectal Surgery
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo-to
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shin Kobayashi
Organization National Cancer Center Hospital East
Division name Colorectal Surgery
Zip code
Address 6-5-1 Kashiwanoha,Kashiwa-shi
TEL 04-7133-1111
Homepage URL
Email shkobaya@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Ministry of Health, Welfare, Labor
Organization
Division
Category of Funding Organization
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
2010 Year 08 Month 05 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
2010 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 04 Month 30 Day
Date of closure to data entry
2012 Year 05 Month 30 Day
Date trial data considered complete
2012 Year 08 Month 30 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 05 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004812

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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