UMIN-CTR Clinical Trial

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
Email	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
Email	irb02syh@ofc.showa-u.ac.jp

Sponsor
Institute	SHOWA University Northern Yokohama Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055877