UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034856 |
|---|---|
| Receipt number | R000038938 |
| Scientific Title | Assessment of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2023/04/07 09:59:21 |
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Basic information
Public title
Assessment of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer
Acronym
MAC for RALS
Scientific Title
Assessment of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer
Scientific Title:Acronym
MAC for RALS
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate effects of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer on physical and psychological state
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analgesia, sedation, and side effect
Key secondary outcomes
variation of psychological state
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
only during brachytherapy
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
| Not applicable |
Gender
Female
Key inclusion criteria
diagnosed with cervical cancer and brachytherapy is planned for treatment
Key exclusion criteria
poor general condition for monitored anesthesia care
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Hirosaki University Hospital
Division name
Anesthesiology
Zip code
0368563
Address
53 Hon-cho, Hirosaki City, Aomori
TEL
+81-172-39-5113
takf5@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kudo |
Organization
Hirosaki University Hospital
Division name
Anesthesiology
Zip code
0368563
Address
53 Hon-cho, Hirosaki City, Aomori
TEL
+81-172-39-5113
Homepage URL
takf5@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of MedicineInstitutional Review Board
Address
5,Zaifucho,Hirosaki,Aomori
Tel
0172395203
rinri@hirosaki-u.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
| 2019 | Year | 01 | Month | 01 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038938
