UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010289 |
|---|---|
| Receipt number | R000012046 |
| Scientific Title | Effectiveness of wound-edge protector in colorectal surgery: a randomized phase II study |
| Date of disclosure of the study information | 2013/03/22 |
| Last modified on | 2018/10/04 16:08:00 |
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Basic information
Public title
Effectiveness of wound-edge protector in colorectal surgery: a randomized phase II study
Acronym
Effectiveness of wound-edge protector in colorectal surgery: a phase II study
Scientific Title
Effectiveness of wound-edge protector in colorectal surgery: a randomized phase II study
Scientific Title:Acronym
Effectiveness of wound-edge protector in colorectal surgery: a phase II study
Region
| Japan |
Condition
Condition
Colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of wound-edge protector in colorectal surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of SSI
Key secondary outcomes
Cost of medical treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Presence of wound-edge protector
Interventions/Control_2
Absence of wound-edge protector
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
Open surgery for colorectal disease
Age of 20 or older
Agreement to the trial before surgery
Key exclusion criteria
Age younger than 20
Disagreement to the trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Sugihara |
Organization
Tokyo Medical and Dental University
Division name
Department of Surgical Oncology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5261
h-kobayashi.srg2@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Kobayashi |
Organization
Tokyo Medical and Dental University
Division name
Center for Minimally Invasive Surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5261
Homepage URL
h-kobayashi.srg2@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 03 | Month | 22 | 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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | 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
| 2013 | Year | 03 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012046
