UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021534 |
|---|---|
| Receipt number | 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 12:06:26 |
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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
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
efilonecnadon@yahoo.co.jp
Sponsor or person
Institute
Jichi Medical University, Department of General Thoracic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024827
