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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018703
Receipt No. 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

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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
Email 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
Email okabayashikoji@gmail.com

Sponsor
Institute Keio university school of medicine department of surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020621

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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