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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044057
Receipt No. 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 2021/04/27

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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
Email miura-n@saiseikai-hp.chuo.fukuoka.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/
Email miura-n@saiseikai-hp.chuo.fukuoka.jp

Sponsor
Institute Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc.
Institute
Department

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
Email 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
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 Open public recruiting
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
2021 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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