UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041514 |
|---|---|
| Receipt number | R000047392 |
| Scientific Title | Japan Robot-Assisted Thoracic Surgery Interest Group Trial 01 |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2023/08/27 11:56:48 |
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Basic information
Public title
prospective survey on relation between the postoperative pain and the number or site of intercostal ports in robotic or video-assisted thoracic surgery
Acronym
prospective survey on postoperative pain in robotic or video-assisted thoracic surgery
Scientific Title
Japan Robot-Assisted Thoracic Surgery Interest Group Trial 01
Scientific Title:Acronym
postoperative pain in robotic or video-assisted thoracic surgery (J-RATSIG 01)
Region
| Japan |
Condition
Condition
robotic or video-assisted thoracic surgery for lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the postoperative pain between robotic and video-assisted thoracic surgeries
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the rate of Numeric Rating Scale of 3 or less on 30th day after surgery
Key secondary outcomes
Pain scores on 10th, 30th, and 90th days after surgery
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
1) 20 years and over
2) Patients who underwent robotic or thoracoscopic lobectomy or segmental resection for lung cancer (including metastatic lung cancer, with or without lymph node dissection)
3) Being able to confirm the patient background in the medical record
4) The maximum wound is 5 cm or less (no thoracotomy device is used)
5) No renal dysfunction (eGFR 40 mL / min or more)
6) No history of open chest surgery (including thoracoscopic surgery) (including contralateral side)
7) Those who have obtained written consent for participation in the research
Key exclusion criteria
1) Patients whose drain was not removed by 7 days after surgery
2) Patients with Grade 3 or higher complications according to the Clavien-Dindo classification (However, postoperative pain of G3 or higher is not excluded)
3) Patients with chest pain before lung cancer surgery
4) Patients using opioids or steroids before lung cancer surgery due to other diseases
5) Patients who are judged by the principal investigator / coordinator to be inappropriate for inclusion in the study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Mie University Hospital
Division name
Thoracic surgery
Zip code
514-8507
Address
2-174, Edobashi, Tsu
TEL
0592315021
k-gucci@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Thoracic surgery
Zip code
5148507
Address
2-174, Edobashi, Tsu
TEL
0592315021
Homepage URL
k-gucci@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University 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
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174, Edobashi, Tsu
Tel
0592315021
kk-sien@med.mie-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
三重大学（三重県）、名古屋大学（愛知県）、名古屋第一赤十字病院（愛知県）、聖隷三方原病院（静岡県）、岡山大学（岡山県）、兵庫医科大学（兵庫県）、トヨタ記念病院（愛知県）、豊橋市民病院（愛知県）、近畿大学（大阪）、愛知県がんセンター中央病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 25 | 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
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
| 2020 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
A prospective, multicenter study will be conducted to compare postoperative pain in patients undergoing robotic or thoracoscopic lobectomy or segmentectomy for lung cancer. Between October 2020 and March 2022, patients who underwent robotic surgery at the research facility were informed of the consent of the study, and the same number of thoracoscopic surgery was registered. We will compare the approaches in post-pain and examine the relationship with the number and position of port wounds. The reason for setting the numbers to the same level is that there is a considerable variation in the ratio of robotic surgery and thoracoscopic surgery depending on the facility. All cases of robotic surgery will be registered, but the extraction method when there are many cases of thoracoscopic surgery will be left to each institution. However, we ask that facilities performing single-port thoracoscopic surgery register as much as possible.
This study is an observational study that does not involve invasiveness, and the current surgical procedures, pain management, drains, etc. at each facility will remain unchanged, but data for analysis will be collected.
For pain questionnaires for study subjects, use the painDETECT Japanese version published in the Pain Clinic Society (attached to a separate sheet). In order to investigate the degree of pain during the postoperative acute period (10 days after surgery) and the chronic stage (30, 90 days after surgery), we will hand over 3 pain questionnaires during hospitalization and mail them from the patient. Store the anonymization correspondence table.
Management information
Registered date
| 2020 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047392
| Research Plan | |
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