UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018703 |
|---|---|
| Receipt number | R000020621 |
| Scientific Title | The assessment of the optimum timing of perioperative changing gloves |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2020/03/03 19:52:41 |
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Basic information
Public title
The assessment of the optimum timing of perioperative changing gloves
Acronym
The assessment of the optimum timing of perioperative changing gloves
Scientific Title
The assessment of the optimum timing of perioperative changing gloves
Scientific Title:Acronym
The assessment of the optimum timing of perioperative changing gloves
Region
| Japan |
Condition
Condition
Colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the need to wear gloves doubly and the optimum timing of changing gloves
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the perforations or damage of medical gloves
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
patients who receive laparoscopic colorectal surgery
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinsei |
| Middle name | |
| Last name | Matsuoka |
Organization
Keio university school of medicine
Division name
department of surgery
Zip code
1608582
Address
35 Shinanomachi Shinjyuku-ku Tokyo
TEL
0353633800
okabayashikoji@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Okabayashi |
Organization
Keio university school of medicine
Division name
department of surgery
Zip code
160-8582
Address
35 Shinanomachi Shinjyuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
okabayashikoji@gmail.com
Sponsor or person
Institute
Keio university school of medicine department of surgery
Institute
Department
Personal name
Funding Source
Organization
Keio university school of medicine department of surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio university school of medicine
Address
35 Shinanomachi Shinjyuku-ku Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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 | 08 | Month | 18 | 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 | 03 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Wear new gloves at the beginning of intra-abdominal procedure and remove them at the end of intra-abdominal procedure. Pour 1L water into the gloves and check the presence of damage of gloves, the location of damage, the operative duration and the presence of wound infection
Management information
Registered date
| 2015 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020621
