UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038728 |
|---|---|
| Receipt number | R000044154 |
| Scientific Title | Comparison of the progress of postoperative ICU between thoracotomy / laparotomy and endoscopic surgery for esophageal cancer |
| Date of disclosure of the study information | 2020/03/15 |
| Last modified on | 2020/07/27 20:03:39 |
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Basic information
Public title
Comparison of the progress of postoperative ICU between thoracotomy / laparotomy and endoscopic surgery for esophageal cancer
Acronym
Comparison of the progress of postoperative ICU between thoracotomy / laparotomy and endoscopic surgery
Scientific Title
Comparison of the progress of postoperative ICU between thoracotomy / laparotomy and endoscopic surgery for esophageal cancer
Scientific Title:Acronym
Comparison of the progress of postoperative ICU between thoracotomy / laparotomy and endoscopic surgery
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the length fo hospital and ICU, oxygenation, of postoperative ICU between thoracotomy / laparotomy and endoscopic surgery for esophageal cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
he length fo hospital and ICU, oxygenation
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
esophageal surgery
Key exclusion criteria
surgery cancel
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | daizoh |
| Middle name | |
| Last name | satoh |
Organization
Juntendo University School of Medicine
Division name
anesthesiology and pain medicinene
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
ds0226@fsinet.or.jp
Public contact
Name of contact person
| 1st name | daizoh |
| Middle name | |
| Last name | satoh |
Organization
Juntendo University School of Medicine
Division name
anesthesiology and pain medicinene
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
ds0226@fsinet.or.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JUNTENDO HOSPITAL
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
kenkyu5858@juntendo.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
| 2020 | Year | 03 | 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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
OBSERVATIONAL STUDY
Management information
Registered date
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044154
