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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010281
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yokosuka Kyosai Hospital
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011963

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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