UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052523 |
|---|---|
| Receipt number | R000059935 |
| Scientific Title | Study of mediastinal structures based on surgical findings |
| Date of disclosure of the study information | 2023/10/17 |
| Last modified on | 2023/10/17 18:40:33 |
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Basic information
Public title
Study of mediastinal structures based on surgical findings
Acronym
Mediastinal structures
Scientific Title
Study of mediastinal structures based on surgical findings
Scientific Title:Acronym
Mediastinal structures
Region
| Japan |
Condition
Condition
mediastinal disease
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although knowledge of the fascial structure of the mediastinum is essential for the safe and reliable performance of surgery, it is an area that has not been well studied. In principle, anatomy is based on findings from cadaveric autopsies, which often differ from surgical findings on living subjects, especially with regard to fascia. The purpose of this study is to clarify the fascial structures constituting the mediastinum from the perspective of surgical anatomy by observing the fascial structures through intraoperative gross findings in cases operated on in our department and reviewing and overseeing these findings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigating the fascial structure in the mediastinum
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are going to undergo a mediastinal surgery in our department
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Nakanishi |
Organization
National hospital organization Saitama hospital
Division name
General thoracic surgery
Zip code
351-0102
Address
2-1 Suwa, Wako, Saitama
TEL
048-462-1101
nakanishi.kozo.tf@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Nakanishi |
Organization
National hospital organization Saitama hospital
Division name
General thoracic surgery
Zip code
351-0103
Address
2-1 Suwa, Wako, Saitama
TEL
048-452-1101
Homepage URL
nakanishi.kozo.tf@mail.hosp.go.jp
Sponsor or person
Institute
National hospital organization Saitama hospital
Institute
Department
Personal name
Funding Source
Organization
none
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 IRB
Address
2-1 Suwa,Wako,Saitama
Tel
048-452-1101
none
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 | 10 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Surgical observation confirms that there are fascial structures in the mediastinum that have not been previously noted. In particular, detailed fascial structures fixing the pericardium in place can be observed.
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059935
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
