UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050856 |
|---|---|
| Receipt number | R000057957 |
| Scientific Title | Natural course of symptoms after thoracic surgery patients: assessment with COPD assessment test |
| Date of disclosure of the study information | 2023/04/15 |
| Last modified on | 2023/04/15 16:58:16 |
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Basic information
Public title
Natural course of symptoms after thoracic surgery patients: assessment with COPD assessment test
Acronym
Natural course of symptoms after thoracic surgery patients: assessment with COPD assessment test
Scientific Title
Natural course of symptoms after thoracic surgery patients: assessment with COPD assessment test
Scientific Title:Acronym
Natural course of symptoms after thoracic surgery patients: assessment with COPD assessment test
Region
| Japan |
Condition
Condition
lung tumor, mediastinal tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the natural course of subjective symptoms after respiratory surgery using the COPD Assessment test
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COPD assessment test results from preoperative to postoperative one year
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
performed elective lung resection or mediastinal tumor resection
Key exclusion criteria
under 19 years old, planned thoracotomy, conversion to thoracotomy, re-operation in thoracic surgery, median sternotomy, robot-assisted thoracic surgery, simultaneous resection of extrathoracic organs, locally invasive lung tumor with bronchoplasty or angioplasty, postoperative recurrence, adjuvant therapy, and Grade III or higher postoperative respiratory complications in Clavien-Dindo classification.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
Joetsu General Hospital
Division name
Division of Thoracic Surgery
Zip code
943-8507
Address
616 Daido-Fukuda, Joetsu, Niigata
TEL
025-524-3000
hommat.tym@gmail.com
Public contact
Name of contact person
| 1st name | Takhiro |
| Middle name | |
| Last name | Homma |
Organization
Joetsu General Hospital
Division name
Division of Thoracic Surgery
Zip code
943-8507
Address
616 Daido-Fukuda, Joetsu, Niigata
TEL
025-524-3000
Homepage URL
hommat.tym@gmail.com
Sponsor or person
Institute
Joetsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Joetsu General Hospital
Address
616 Daido-Fukuda, Joetsu, Niigata
Tel
025-524-3000
hommat.tym@gmail.com
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
| 2023 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.micenavi.jp/jss120/search/detail_program/id:3067
Publication of results
Partially published
Result
URL related to results and publications
https://www.micenavi.jp/jss120/search/detail_program/id:3067
Number of participants that the trial has enrolled
154
Results
All surgical procedures showed the highest score one week after surgery compared to before surgery, mediastinal tumor +2.5 points, partial lung resection +6.6 points, segmental resection +13.2 points, lung lobectomy +7 points.
Results date posted
| 2023 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent elective surgery at our department from April 2013 to March 2016
Participant flow
Twenty-seven patients were excluded from the analysis, including 16 mediastinal tumors, 35 partial lung resections, 29 segmentectomies, and 74 lobectomies.
Adverse events
None
Outcome measures
All surgical procedures showed the highest score one week after surgery compared to before surgery, mediastinal tumor +2.5 points, partial lung resection +6.6 points, segmental resection +13.2 points, lung lobectomy +7 points. It was 1 point. The time to reach within +3 points before surgery was 1 month after surgery for partial pulmonary resection, and 2 months after surgery for segmental resection and lobectomy. In mediastinal tumors and middle lobe/glossectomy, there was no change even after 1 week after surgery, and remained within +3 points before surgery. There was no difference in postoperative tendency due to other evaluation factors
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2023 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057957
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