UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004643 |
|---|---|
| Receipt number | R000005252 |
| Scientific Title | Comparison of various sealing and cutting devices in VATS lobectomy |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2015/02/06 12:14:23 |
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Basic information
Public title
Comparison of various sealing and cutting devices in VATS lobectomy
Acronym
Comparison of various sealing and cutting devices in VATS lobectomy
Scientific Title
Comparison of various sealing and cutting devices in VATS lobectomy
Scientific Title:Acronym
Comparison of various sealing and cutting devices in VATS lobectomy
Region
| Japan |
Condition
Condition
The disease that is necessary for lobectomy
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
VATS spread for an approach of the lobectomy, but there are still many technical problems. We need proficiency for vascular divide to perform in a limited operation field. The coagulotomy devices already spread, and it is used for vascular divide in each field, and it contributes to the simpleness and easiness of the procedure and safe improvement. It seems that it is very effective in pulmonary vascular divide. However, a supersonic wave type and bipolar type are present, and there is time to hesitate about choice. We compare various coagulotomy devices for the establishment of the method of simpler and easier and safe pulmonary vascular divide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The burst pressure measurement and a tissue evaluation of the divided site in the sample, duration of the postoperative pulmonary fistula, a drain custody period, quantity of drain drainage, generic postoperative blood data.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Vascular divided by Enseal® (bipolar type)
Interventions/Control_2
Vascular divided by LigaSure® (bipolar type)
Interventions/Control_3
Vascular divided by Harmonic® (supersonic wave type)
Interventions/Control_4
Vascular divided by the ligation that we do not use a coagulotomy device
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 that it is planned lobectomy
Key exclusion criteria
When severe adhesion is expected and there are severe complications
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Amano |
Organization
Shinshu University, School of Medicine
Division name
Department of Surgery
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-2657
surgery2@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Toishi |
Organization
Shinshu University, School of Medicine
Division name
Department of Surgery
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-2657
Homepage URL
mtoi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University, School of Medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 04 | Month | 01 | 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
Results
Vessel-sealing device is simple and safe to use in thoracoscopic lobectomy involving mediastinal lymph node dissection for primary lung cancer. Furthermore, none of the Vessel-sealing devices used in this study presented any observable differences in quality that could lead to clinical problems.
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
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2015 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005252
