UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028127 |
|---|---|
| Receipt number | R000032198 |
| Scientific Title | Regular administration of acetaminophen in complete video assisted thoracic surgery (VATS) for abbreviation of extradural anesthesia |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2017/07/07 15:07:45 |
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Basic information
Public title
Regular administration of acetaminophen in complete video assisted thoracic surgery (VATS) for abbreviation of extradural anesthesia
Acronym
TONEYAMA-CVATS STUDY
Scientific Title
Regular administration of acetaminophen in complete video assisted thoracic surgery (VATS) for abbreviation of extradural anesthesia
Scientific Title:Acronym
TONEYAMA-CVATS STUDY
Region
| Japan |
Condition
Condition
Lung tumors
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of acetaminophen in patients undergoing complete video assisted thoracic surgery (complete VATS)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety (the rates of patients who complete acetaminophen treatment)
Key secondary outcomes
VAS scale (at rest and movement)
The number of use of analgesics during the perioperative period
Postoperative nausea or vomiting
The number of use of antiemetic drug during the perioperative period
The incidence of adverse effects
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Complete VATS is scheduled.
2. Patients must be aged 20 years or older.
3. Written informed consent is provided by the patient.
Key exclusion criteria
1. Patients with a history of allergy to any component of the study medication.
2. Inappropriate for enrollment based on the judgment of the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiyasu Takeuchi |
Organization
National Hospital Organization Toneyama Hospital
Division name
General Thoracic Surgery
Zip code
Address
5-1-1 Toneyama, Toyonaka-City, Osaka
TEL
0668532001
ytakeuch@toneyama.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruka Kawai |
Organization
National Hospital Organization Toneyama Hospital
Division name
General Thoracic Surgery
Zip code
Address
5-1-1 Toneyama, Toyonaka-City, Osaka
TEL
0668532001
Homepage URL
t.kawai@toneyama.go.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital
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
Address
Tel
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
国立病院機構刀根山病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 07 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2017 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032198
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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