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

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 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


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

Value
https://center6.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