UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024660
Receipt number R000027373
Scientific Title the relationship between VATS and postoperative quality of life
Date of disclosure of the study information 2016/10/31
Last modified on 2019/11/03 13:18:06

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Basic information

Public title

the relationship between VATS and postoperative quality of life

Acronym

VATS and postoperative quality of life

Scientific Title

the relationship between VATS and postoperative quality of life

Scientific Title:Acronym

VATS and postoperative quality of life

Region

Japan


Condition

Condition

the patients undergoing VATS lobectomy

Classification by specialty

Surgery in general Anesthesiology Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to identify chronic pain and life function

Basic objectives2

Others

Basic objectives -Others

the relationship of daily life

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

QOR 40 chronic pain

Key secondary outcomes

SF8 TMIG Index WHODAS sleep index


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Questionnaire
Actigraph

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

elective VATS lobectomy under general anesthesia
Seven or more days of hospitalization is expected

Key exclusion criteria

post VATS surgery patients
use of sedatives
Patient with mental illness or neuropathy
Patient preoperative evaluation is difficult

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Mitsuru
Middle name
Last name Ida

Organization

Nara Medical University

Division name

Anesthesiology

Zip code

6348521

Address

840 Shijo-cho, Kashihara, Nara 634-8522, Japan

TEL

09079627114

Email

nwnh0131@yahoo.co.jp


Public contact

Name of contact person

1st name Mitsuru
Middle name
Last name Ida

Organization

Nara Medical University

Division name

Anesthesiology

Zip code

6348521

Address

840 Shijo-cho, Kashihara, Nara 634-8522, Japan

TEL

0744-22-3051

Homepage URL


Email

nwnh0131@yahoo.co.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

non

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nara Medical University

Address

Kashihara shijo 840

Tel

09079627114

Email

nwnh0131@yahoo.co.jp


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 10 Month 31 Day


Related information

URL releasing protocol

www

Publication of results

Unpublished


Result

URL related to results and publications

www

Number of participants that the trial has enrolled

24

Results

Refer to publication

Results date posted

2019 Year 11 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Refer to publicatipn

Participant flow

Refer to publicatipn

Adverse events

Refer to publicatipn

Outcome measures

Refer to publicatipn

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 11 Day

Date of IRB

2016 Year 08 Month 18 Day

Anticipated trial start date

2016 Year 10 Month 31 Day

Last follow-up date

2018 Year 09 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 31 Day

Last modified on

2019 Year 11 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027373


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name