UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013930 |
|---|---|
| Receipt number | 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 12:40:22 |
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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
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
motono@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015260
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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