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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028127
Receipt No. 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

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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
Email 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
Email t.kawai@toneyama.go.jp

Sponsor
Institute Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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