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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034261
Receipt No. R000038954
Scientific Title Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)
Date of disclosure of the study information 2018/09/25
Last modified on 2018/09/25

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Basic information
Public title Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)
Acronym Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)
Scientific Title Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)
Scientific Title:Acronym Multicenter prospective observational study for the management of air leakage after pulmonary resection (ILO1805)
Region
Japan

Condition
Condition Air leakage after pulmonary resection
Classification by specialty
Surgery in general Chest surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the present trend for management of air leakage after pulmonary resection in Japan, and to inspect the feasibility of conducting prospective randomized controlled study by estimating the optimal management method with analyzing the period of postoperative air leakage of each methods (water seal, continuous suction, and using digital suction system).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The period of postoperative air leakage by each management methods (water seal, continuous suction, and using digital suction system).
Key secondary outcomes 1) Frequency in use of each management methods of postoperative air leakage
2) Occurrence rate of postoperative air leakage by operative procedures
3) Occurrence rate of prolonged (for more than 7days after surgery) air leakage

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who were clinically diagnosed with pulmonary tumor and underwent complete resection (partial resection, segmentectomy, lobectomy, and bi-lobectomy)
Key exclusion criteria 1) The patients who underwent pneumonectomy.
2) The patients who underwent bronchoplasty or chest wall resection.
3) The patients who underwent surgical resection for the treatment of emphysema or inflammatory lung disease.
4) The patients who underwent surgery for the purpose of only biopsy, and were not achieved complete resection.
5) The patients who denied the registration for this study.
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Adachi
Organization Kanto Rosai Hospital
Division name Department of Thoracic Surgery
Zip code
Address 1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan
TEL 044-411-3131
Email adachi-fam@white.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Adachi
Organization Kanto Rosai Hospital
Division name Department of Thoracic Surgery
Zip code
Address 1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan
TEL 044-411-3131
Homepage URL
Email adachi-fam@white.plala.or.jp

Sponsor
Institute International Lung-clinical-Research Organization
Institute
Department

Funding Source
Organization International Lung-clinical-Research Organization
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
Address
Tel
Email

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 春日部市立医療センター(埼玉県)、国立病院機構東埼玉病院(埼玉県)、埼玉県立循環器呼吸器病センター(埼玉県)、埼玉医大付属総合医療センター(埼玉県)、東京歯科大学付属市川病院(千葉県)、独協大学附属病院(栃木県)、帝京大学付属溝口病院(神奈川県)、帝京大学附属病院(東京都)、奈良県立医科大学付属病院(奈良県)、浜松医科大学付属病院(静岡県)、山形県立中央病院(山形県)、山形大学附属病院(山形県)、神奈川県立循環器・呼吸器病センター(神奈川県)、関東労災病院(神奈川県)、済生会横浜市南部病院(神奈川県)、藤沢湘南台病院(神奈川県)、平塚共済病院(神奈川県)、横須賀共済病院(神奈川県)、横須賀市立うわまち病院(神奈川県)、横浜医療センター(神奈川県)、横浜市立大学附属病院(神奈川県)、横浜市立大学附属市民総合医療センター(神奈川県)、横浜南共済病院(神奈川県)、横浜労災病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 25 Day
Last follow-up date
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information <Factors that will be registered>
Age, Gender, Patients' height, Body weight, Smoking history(Brinkman Index), Existence of COPD, Existence of IPF, The history of using steroid, Date of operation, Extent of lung resection, Existence of ittraopertive adhesion, Intraoperative use of Fibrin-glue, Devices that used in transection of interlobar fissure, Type and size of chest drainage tube, Final pathological diagnosis, The method of managing chest drainage tube, Pressure of continuous suction of chest tube, The type of chest drainage bag, The degree of air leakage at the time when the operation is just finished, The degree of air leakage at the morning of postoeprative day1, Date of changing the method of management of chest drainage, Date of disappearance of air leakage, Date of chest tube removal, Existence of prolonged air leakage, Occurence of pneumothorax after chest drain removal.

Management information
Registered date
2018 Year 09 Month 25 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038954

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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