UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010281 |
|---|---|
| Receipt number | R000011963 |
| Scientific Title | A randomised controlled trial about clinical effect of closed subcutaneous drain against incisional surgical site infection in colorectal surgery |
| Date of disclosure of the study information | 2013/03/19 |
| Last modified on | 2013/03/19 16:43:20 |
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Basic information
Public title
A randomised controlled trial about clinical effect of closed subcutaneous drain against incisional surgical site infection in colorectal surgery
Acronym
A RCT about clinical effect of closed subcutaneous drain against incisional surgical site infection
Scientific Title
A randomised controlled trial about clinical effect of closed subcutaneous drain against incisional surgical site infection in colorectal surgery
Scientific Title:Acronym
A RCT about clinical effect of closed subcutaneous drain against incisional surgical site infection
Region
| Japan |
Condition
Condition
Colorectal disorder
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze whether closed subcutaneous drain reduce the incidence of incisional SSI in colorectal surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of incisional SSI
Key secondary outcomes
Hospital stay after surgery
cost effectiveness
the number of days of wound healing after infection
Incidence of seroma
Incidence of wound maceration
Incidence of wound dehiscence
Incidence of reoperation
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
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Control group
Abdominal incision were closed with 1-Vicryl for the fascia and 4-0PDS subcuticular sutures for the skin
Interventions/Control_2
Trial group
Abdominal incision were closed with 1-Vicryl for the fascia and 4-0PDS subcuticular sutures for the skin.In traial group,the 15 Fr Blake drain was inserted between fascia and skin
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 surgery
Written informed consent
Key exclusion criteria
Appendectomy
Hernia repair
Laparoscopic operation without additional skin incision
Re-do operations before the end of wound healing of the primary operation
History of radiotherapy in lower abdomen Emergency operation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Watanabe |
Organization
Yokosuka Kyosai Hospital
Division name
Department of Surgery
Zip code
Address
1-16 Yonegahama street
TEL
046-822-2710
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Kawamoto |
Organization
Yokosuka Kyosai Hospital
Division name
1-16 Yonegahama street
Zip code
Address
TEL
046-822-2710(ext.7718)
Homepage URL
Sponsor or person
Institute
Yokosuka Kyosai Hospital
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
None
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
横須賀共済病院（神奈川県）/Yokosuka kyosai Hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 19 | Day |
Last modified on
| 2013 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011963
