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

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 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


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

Value
https://center6.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