UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049049 |
|---|---|
| Receipt number | R000055877 |
| Scientific Title | Prospective observational study on respiratory surgery pain and pre- and postoperative examination |
| Date of disclosure of the study information | 2022/09/29 |
| Last modified on | 2022/09/28 12:10:58 |
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Basic information
Public title
Prospective observational study on respiratory surgery pain and pre- and postoperative examination
Acronym
Prospective observational study on respiratory surgery pain and pre- and postoperative examination
Scientific Title
Prospective observational study on respiratory surgery pain and pre- and postoperative examination
Scientific Title:Acronym
Prospective observational study on respiratory surgery pain and pre- and postoperative examination
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients undergoing surgery for lung tumors at this hospital will be included. To observe whether the length of the skin incision, the number of skin incisions, the presence of intercostal opening (with or without thoracotomy), the volume of specific brain regions measured by preoperative MRI, STAI and other preoperative factors are related to postoperative pain (Numerical Rating Scale NRS) or postoperative pain assessed by the EuroQOL 5 dimensions 5-level (EQ-5D-5L) Observe whether they are related to quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
EQ-5D-5L
Key secondary outcomes
Changes in NRS, frequency of abrupt analgesic use, sleep disturbances, depressed mood, decreased motivation, autonomic symptoms (vertigo, palpitations, abnormal sensations in extremities), changes in respiratory function tests, inflammatory findings in blood draws, rehabilitation status, presence of death or adverse event events, ad hoc outpatient visits
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing lung tumor surgery at Showa University Northern Yokohama Hospital.
(2) Patients who are 20 years of age or older at the time of obtaining consent.
Key exclusion criteria
1) When the research content is explained to the patient prior to surgery and consent cannot be obtained.
2) In cases where the influence of pain changes during the postoperative period, such as when the patient suffers from other diseases, or in cases where continuous evaluation is difficult.
3) In the case of advanced cognitive decline and when the physician in charge of the research determines that the patient is ineligible for the study.
4) Unacceptable deficiencies in the questionnaires obtained in part or throughout the entire study.
5) If the subject has suffered from intracranial diseases in the past.
6) Has a recognized diagnosis of mental illness. or regular oral medication for psychiatric illnesses within the past 30 days (including sleep disorders and dementia).
7) Patients taking antihistamines or analgesics for chronic pain.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinnnosuke |
| Middle name | |
| Last name | Takamiya |
Organization
SHOWA University Northern Yokohama Hospital
Division name
Department of Surgery, Division of Chest Surgery
Zip code
224-8503
Address
35-1, Kayakisaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
irb02syh@ofc.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinnnosuke |
| Middle name | |
| Last name | Takamiya |
Organization
SHOWA University Northern Yokohama Hospital
Division name
Department of Surgery, Division of Chest Surgery
Zip code
2110021
Address
35-1, Kayakisaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
Homepage URL
irb02syh@ofc.showa-u.ac.jp
Sponsor or person
Institute
SHOWA University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Northern Yokohama Hospital Clinical Trial Support Office
Address
35-1, Kayakisaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
Tel
045-949-7118
irb02syh@ofc.showa-u.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
昭和大学横浜市北部病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 29 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients undergoing surgery for lung tumors at this hospital will be included. To observe whether the length of the skin incision, the number of skin incisions, the presence of intercostal opening (with or without thoracotomy), the volume of specific brain regions measured by preoperative MRI, STAI and other preoperative factors are related to postoperative pain (Numerical Rating Scale NRS) or postoperative pain assessed by the EuroQOL 5 dimensions 5-level (EQ-5D-5L) Observe whether they are related to quality of life.
Management information
Registered date
| 2022 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055877
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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