UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019356 |
|---|---|
| Receipt number | R000022292 |
| Scientific Title | The cleansing ability of novel microfiber cloth on laparoscope |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2017/12/19 13:32:37 |
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Basic information
Public title
The cleansing ability of novel microfiber cloth on laparoscope
Acronym
The cleansing ability of novel microfiber cloth on laparoscope
Scientific Title
The cleansing ability of novel microfiber cloth on laparoscope
Scientific Title:Acronym
The cleansing ability of novel microfiber cloth on laparoscope
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to assess the cleansing ability of novel microfiber cloth on laparoscope
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency and time to intraoperatively wipe laparoscope
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
wiping laparoscopy by microfiber cleansing cloth
Interventions/Control_2
wiping laparoscopy by conventional gauze
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal cancer patients who will undergo laparoscopic surgery
Key exclusion criteria
Colorectal cancer patients who will undergo open surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Hasegawa |
Organization
Department of surgery, School of Medicine, Keio university
Division name
general and gastrointestinal surgery
Zip code
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
hasegawa@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Okabayashi |
Organization
Department of surgery, School of Medicine, Keio university
Division name
general and gastrointestinal surgery
Zip code
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
ken.d05sm098@gmail.com
Sponsor or person
Institute
Department of surgery, School of Medicine, Keio university
Institute
Department
Personal name
Funding Source
Organization
Department of surgery, School of Medicine, Keio 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
| 2015 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 15 | Day |
Last modified on
| 2017 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022292
