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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013930
Receipt No. R000015260
Scientific Title Evaluation of a new protocol for chest tube removal after lobectomy with high drainage volume: a randomized study
Date of disclosure of the study information 2014/05/12
Last modified on 2019/05/16

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Basic information
Public title Evaluation of a new protocol for chest tube removal after lobectomy with high drainage volume: a randomized study
Acronym Evaluation of a new chest tube removal protocol after lobectomy: a randomized study
Scientific Title Evaluation of a new protocol for chest tube removal after lobectomy with high drainage volume: a randomized study
Scientific Title:Acronym Evaluation of a new chest tube removal protocol after lobectomy: a randomized study
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of optimal removable drainage volume after lobectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Rate of patients who were removed drainage tube at 2nd days after lobectomy
Key secondary outcomes length of drainage tube placement, rate of incomplete lung expansion, complication after lobectomy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 drainage volume
450ml per day
2 days after surgery
Interventions/Control_2 drainage volume
200ml per day
2 days after surgery
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who underwent more than lobectomy and mediastinal lymphadenectomy.
2. Patients without bleeding, chylothorax, air leakage, or thoracic infection at 2 days after surgery.
3. Written informed consent were obtained from patients.
Key exclusion criteria 1. Patients who underwent ipsilateral pneumonectomy.
2. Patients with bleeding, chylothorax, air leakage, or thoracic infection at 2 days after surgery.
3. Patients with coagulation disorder.
4. Patients who were regarded as inappropriate for the study.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Hidetaka
Middle name
Last name Uramoto
Organization Kanazawa Medical University
Division name Thoracic Surgery
Zip code 920-0856
Address 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan
TEL 076-286-2211
Email sagawam@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name Nozomu
Middle name
Last name Motono
Organization Kanazawa Medical University
Division name Thoracic Surgery
Zip code 920-0856
Address 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan
TEL 076-286-2211
Homepage URL
Email motono@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
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 nstitutional Review Boards of Kanazawa Medical University
Address 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan
Tel 076-218-8346
Email tiken@kanazawa-med.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 金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 70
Results
70 patients met inclusion criteria and were randomized. 35 patients divided into the High group, and 35 patients the Low group. There was no significant difference between the two groups (p=0.31). The average of duration of chest tube placement was 2.05 days in the High group, 2.31 days in the Low group. The duration of chest tube placement in the High group was significantly shorter than that in the Low group (p=0.02). There were no major postoperative complications in the both groups.
Results date posted
2019 Year 05 Month 16 Day
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
2014 Year 05 Month 12 Day
Date of IRB
2014 Year 05 Month 12 Day
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 12 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015260

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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