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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018507
Receipt No. R000021421
Scientific Title Randomized control study comparing quality of life after single-port versus conventional video-assisted thoracoscopic surgery for lung cancer
Date of disclosure of the study information 2015/07/31
Last modified on 2015/08/04

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Basic information
Public title Randomized control study comparing quality of life after single-port versus conventional video-assisted thoracoscopic surgery for lung cancer
Acronym RCT of single-port versus conventional VATS for lung cancer
Scientific Title Randomized control study comparing quality of life after single-port versus conventional video-assisted thoracoscopic surgery for lung cancer
Scientific Title:Acronym RCT of single-port versus conventional VATS for lung cancer
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Compariosn of post operative pain and QOL between single incision and conventional VATS
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes post operative pain(Numeric Rating Scale)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 single port
Interventions/Control_2 conventional
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 c-stage I primary lung cancer
Key exclusion criteria multiple organ cancer
low cardiopumonary reserve,
impossible one lung ventilation
BMI>35
pregnancy
psychiatric disorder
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichi Yamashita
Organization Fukuoka University Hospital
Division name Department of General Thoracic surgery
Zip code
Address 7-45-1, Nanakuma,Jonanku, Fukuoka, Japan
TEL 092-801-1011
Email yamashi1@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichi Yamashita
Organization Fukuoka University Hospital
Division name Department of General Thoracic surgery
Zip code
Address 7-45-1, Nanakuma,Jonanku, Fukuoka, Japan
TEL 092-801-1011
Homepage URL http://www.med.fukuoka-u.ac.jp/thoracic/index.html
Email yamashi1@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Department of General Thoracic surgery
Institute
Department

Funding Source
Organization Fukuoka University Hospital
Department of General Thoracic surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 福岡大学病院呼吸器・乳腺内分泌・小児外科

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 31 Day

Related information
URL releasing protocol http://www.med.fukuoka-u.ac.jp/thoracic/index.html
Publication of results Unpublished

Result
URL related to results and publications http://www.med.fukuoka-u.ac.jp/thoracic/index.html
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 Preinitiation
Date of protocol fixation
2015 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 31 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 04 Month 30 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 31 Day
Last modified on
2015 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021421

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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