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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004643
Receipt No. 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

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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
Email 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
Email mtoi@shinshu-u.ac.jp

Sponsor
Institute Shinshu University, School of Medicine, Department of Surgery
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005252

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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