UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004001 |
|---|---|
| Receipt number | 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 21:10:04 |
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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
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
shkobaya@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004812
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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