UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052801 |
|---|---|
| Receipt number | R000060253 |
| Scientific Title | Incidence of foreign body remaining and lost specimen at operation theater |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2023/11/14 19:13:57 |
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Basic information
Public title
Incidence of foreign body remaining and lost specimen at operation theater of tertiary medical institution for 5 years: A retrospective study
Acronym
Incidence of foreign body remaining and lost specimen at operation theater
Scientific Title
Incidence of foreign body remaining and lost specimen at operation theater
Scientific Title:Acronym
Incidence of foreign body remaining and lost specimen at operation theater
Region
| Japan |
Condition
Condition
Surgical operation
Classification by specialty
| Surgery in general | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective study is to elucidate the incidence of foreign body remaining and lost specimen at operating theater at tertiary medical institution. Additionally, in this study, we aim that to clarify the independent factors for influencing those incidences.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of foreign body remaining and lost specimen at operating theater for 5 years
Key secondary outcomes
Independent factors for incidence of foreign body remaining and lost specimen
Incidence in each surgical department
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 underwent surgery in operating theater of Sapporo Medical University School of Medicine
Key exclusion criteria
Patients who ask rejecting to participate in this study
Target sample size
37000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Chaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-611-2111
chakitomohiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Chaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
+81-11-611-2111
Homepage URL
https://web.sapmed.ac.jp/masui/patients/research/index.html
chakitomohiro@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
Institutional review board of Sapporo Medical University
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido
Tel
+81-11-611-2111
ji-rskk@sapmed.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
| 2023 | Year | 11 | Month | 15 | 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
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Incidence of foreign body remaining
Incidence of lost specimen
Surgery department
Surgery duration
Surgery time
Years of experience of the nurse at the time of the incident
Occupation to take out equipment when an incident occurs
Management information
Registered date
| 2023 | Year | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060253
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
