UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044057 |
|---|---|
| Receipt number | R000049678 |
| Scientific Title | Clinical trial to examine the safety of early removal of chest tube after thoracic surgery |
| Date of disclosure of the study information | 2021/04/27 |
| Last modified on | 2023/11/04 19:15:47 |
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Basic information
Public title
Clinical trial to examine the safety of early removal of chest tube after thoracic surgery
Acronym
Clinical trial to examine the safety of early removal of chest tube after thoracic surgery
Scientific Title
Clinical trial to examine the safety of early removal of chest tube after thoracic surgery
Scientific Title:Acronym
Clinical trial to examine the safety of early removal of chest tube after thoracic surgery
Region
| Japan |
Condition
Condition
Diseases scheduled for thoracic surgery
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims for examine the safety and clinical efficacy of removing the chest tube, which is generally placed after thoracic surgery, in the operating room after awakening from anesthesia under certain conditions and performing postoperative management without the chest tube.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Chest tube drain reinsertion rate
Key secondary outcomes
Postoperative hospital stay
Post-operative complications, mortality within 30 days, in-hospital mortality
Postoperative pain (NRS is described twice a day (9:00, 15:00) from the day after surgery to the day of discharge, and once a day (9:00) from the day of discharge to the day of the first outpatient visit. Evaluation of additional amount of analgesic and total oral dose of analgesic until the first outpatient day after surgery. Evaluation of NRS by surgical approach)
Inpatient medical expenses
Clinical findings (type of disease, surgical procedure, age, gender, height, weight, body mass index, smoking history, performance status, preoperative comorbidities), laboratory findings (blood count / biochemistry / coagulation test, respiratory function test), imaging findings (chest X-ray, computed tomography), intraoperative findings (surgical approach [video-assisted thoracoscopic surgery, thoracoscopic-assisted surgery, thoracotomy], intrathoracic adhesions, air leaks, methods of repairing air leaks)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Chest tubes, which are commonly placed after thoracic surgery, are removed in the operating room.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are scheduled to undergo the following surgical procedures at Saiseikai Fukuoka General Hospital.
Surgery with resection of lung parenchyma (partial resection, segmentectomy, lobectomy)
Surgery without resection of lung parenchyma (surgery for mediastinum, pleural disease, etc.)
2. Patients whose age at the time of surgery is 15 years or older.
3. Patients who received an explanation of this study and obtained written consent from the patient or his / her substitute. In the case of minors, patients who have obtained written consent from the patient and their parents.
4. Patients who can answer the questionnaire for pain evaluation.
Key exclusion criteria
1. Patients scheduled for surgery with resection of the lung parenchyma show severe emphysematous changes and interstitial lung disease in the remaining lungs on preoperative imaging.
2. Patients who require combined resection and / or reconstruction of adjacent organs / structures such as the rib cage and diaphragm.
3. Patients who require continuous chest tube drainage after surgery, such as empyema.
4. Patients with high-risk factors for bleeding (patients with hemorrhagic disease, patients taking antithrombotic / anticoagulant) or with chest trauma that require observation of postoperative bleeding.
5. Other patients whose participation in this study was judged to be inappropriate by the surgeon.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Miura |
Organization
Saiseikai Fukuoka General Hospital
Division name
Department of surgery
Zip code
810-0001
Address
1-3-46, Tenjin, Chuo-ku, Fukuoka 810-0001, Japan
TEL
092-771-8151
nooir_nooka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Miura |
Organization
Saiseikai Fukuoka General Hospital
Division name
Department of surgery
Zip code
810-0001
Address
1-3-46, Tenjin, Chuo-ku, Fukuoka 810-0001, Japan
TEL
092-771-8151
Homepage URL
https://www.saiseikai-hp.chuo.fukuoka.jp/
nooir_nooka@yahoo.co.jp
Sponsor or person
Institute
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Saiseikai Fukuoka General Hospital
Address
1-3-46, Tenjin, Chuo-ku, Fukuoka 810-0001, Japan
Tel
092-771-8151
ikyoku2@saiseikai-hp.chuo.fukuoka.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
| 2021 | Year | 04 | Month | 27 | 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
151
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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049678
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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