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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021534
Receipt No. R000024827
Scientific Title Randomized control study comparing wound pain at extraction sites of lobe after video-assisted thoracoscopic lobectomy for lung cancer
Date of disclosure of the study information 2016/03/22
Last modified on 2016/03/22

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Basic information
Public title Randomized control study comparing wound pain at extraction sites of lobe after video-assisted thoracoscopic lobectomy for lung cancer
Acronym RCT of extraction sites of lobe after VATS lobectomy for lung cancer
Scientific Title Randomized control study comparing wound pain at extraction sites of lobe after video-assisted thoracoscopic lobectomy for lung cancer
Scientific Title:Acronym RCT of extraction sites of lobe after VATS lobectomy for lung cancer
Region
Japan

Condition
Condition Clinical stage 1 lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Wound pain at the extraction sites of lobe is reviewed to improve quality of life after VATS lobectomy for lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative pain evaluation by Numerical Rating Scale on POD 10 and 30, frequency and type of analgesics
Key secondary outcomes extraction bag lavage cytlogy,
postoperative complication including wound,
postoperative hospital days

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Posterior group by extraction from posterior axillary line of 7th or 8th ICS
Interventions/Control_2 Anterior group by extraction from posterior axillary line of 5th or 6th ICS
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 a.Clinical stage 1 lung cancer
b.Port access lobectomy
c.Curative operation
Key exclusion criteria a.Right middle lobectomy or Bi-lobectomy
b.Analgesics is preoperatively used.
c.Coverted to open thoracotomy
d.Pleural invasion
e.Positive pleural lavage cytology
f.Major tranquilizer is used.
g.Thoracic drainage is required for h.Longer than 7 days after surgery.
Redo operation, re-thoracic drainage
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Endo
Organization Jichi Medical University
Division name 3311-1, Yakushiji, Department of General Thoracic Surgery
Zip code
Address 3311-1, Yakushiji, Shimotsuke-shi, Tochigi, Japan
TEL 0285-58-7368
Email tcvshun@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoki Shibano
Organization Jichi Medical University
Division name Department of General Thoracic Surgery
Zip code
Address 3311-1, Yakushiji, Shimotsuke-shi, Tochigi, Japan
TEL 0285-58-7368
Homepage URL
Email efilonecnadon@yahoo.co.jp

Sponsor
Institute Jichi Medical University, Department of General Thoracic Surgery
Institute
Department

Funding Source
Organization Jichi Medical University, Department of General Thoracic Surgery
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

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 22 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 Preinitiation
Date of protocol fixation
2016 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 18 Day
Last modified on
2016 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024827

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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