UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050857 |
|---|---|
| Receipt number | R000046177 |
| Scientific Title | Uniportal vs multi portal VATS lobectomy and segmentectomy: Natural course of symptoms with COPD assessment test |
| Date of disclosure of the study information | 2023/04/15 |
| Last modified on | 2023/04/15 17:32:11 |
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Basic information
Public title
Uniportal vs multi portal VATS lobectomy and segmentectomy: Natural course of symptoms with COPD assessment test
Acronym
Uniportal vs multi portal VATS lobectomy and segmentectomy: Natural course of symptoms with COPD assessment test
Scientific Title
Uniportal vs multi portal VATS lobectomy and segmentectomy: Natural course of symptoms with COPD assessment test
Scientific Title:Acronym
Uniportal vs multi portal VATS lobectomy and segmentectomy: Natural course of symptoms with COPD assessment test
Region
| Japan |
Condition
Condition
lung tumor
Classification by specialty
| Chest surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze postoperative natural course causes of thoracic patients challenging conventional multiple-port VATS (CVATS) and conversion to thoracotomy and postoperative pain to provide indications for VATS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COPD Assessment Test score
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
All patients who were admitted to Toyama University Hospital (Toyama, Japan) for elective VATS lobectomy and segmentectomy between October 2019 and September 2021.
Key exclusion criteria
Partial lung resection, aged 19 years or younger, planned 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, Clavien-Dindo classification Grade III or higher postoperative complications, postoperative chemotherapy, targeted therapy, or radiation therapy within 3 months after surgery, and those who refused to participate in the research based on the published research information.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
University of Toyama
Division name
Division of Thoracic Surgery
Zip code
930-0194
Address
Sugitani 2630, Toyamatani
TEL
076-434-7330
homma@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
University of Toyama
Division name
Division of Thoracic Surgery
Zip code
930-0194
Address
Sugitani 2630, Toyamatani
TEL
076-434-7330
Homepage URL
homma@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Center for Clinical Research, University of Toyama
Address
Sugitani 2630, Toyama
Tel
076-415-8857
rinri@adm.u-toyama.ac.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
| 2023 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.hosp.u-toyama.ac.jp/tiken/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.hosp.u-toyama.ac.jp/tiken/
Number of participants that the trial has enrolled
92
Results
Uniportal VATS lowers postoperative symptoms earlier in the CAT score
Results date posted
| 2023 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
lung tumor cases requiring lobectomy or segmentectomy
Participant flow
Perioperative CAT was taken regularly for 3 months after surgery.
Adverse events
None
Outcome measures
COPD assessment test score, peroperative factors
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in progress
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/ctr_e/ctr_view.cgi?recptno=R000046177
