UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007137
Receipt number R000007998
Scientific Title Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy
Date of disclosure of the study information 2012/01/25
Last modified on 2015/01/26 09:05:03

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Basic information

Public title

Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy

Acronym

Plan Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy

Scientific Title

Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy

Scientific Title:Acronym

Plan Randomized Trial between LigaSure Small Jaw Versus Conventional Vessel Ligation in Thyroidectomy

Region

Japan


Condition

Condition

Thyroid cancer

Classification by specialty

Endocrine surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine whether the study treatment using the LigaSure Small Jaw System is superior to the current standard treatment with vessel ligation using sutures in operating time and other endpoints in a randomized controlled trial conducted in patients undergoing thyroidectomy for thyroid cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Operating time

Key secondary outcomes

amount of blood loss, amount of drainage, lymphatic leakage, length of hospital stay, duration of drainage, comparison of medical costs (labor costs, number of sutures used, operating time, etc.), fatigue levels of the operator, incidence of intraoperative adverse events, incidence of postoperative adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

LigaSure Small Jaw group

Interventions/Control_2

conventional ligation group

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients aged 20 years or older
2) Patients scheduled to undergo total thyroidectomy with unilateral dissection for thyroid cancer
3) Patients with no history of similar surgery
4) Patients with preserved major organ function
5) Patients providing written informed consent for participation in the study

Key exclusion criteria

1) Patients requiring concurrent resection of the trachea, etc. due to adjacent organ involvement
2) Patients with active bacterial and/or fungal infections
3) Patients receiving continued systemic (oral or intravenous) steroids
4) Patients with uncontrolled diabetes mellitus (HbA1c >8.0%)
5) Patients with psychiatric disorder or psychiatric symptoms that would preclude the participation in the study
6) Any others judged by the doctor in charge to be ineligible for subjects in the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Miyauchi

Organization

Kuma Hospital, Shinkokai Medical Corporation

Division name

Department of Surgery

Zip code


Address

8-2-35, Shimoyamate-dori, Chuo-ku, Kobe City, Hyogo, 650-0011

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kuma Hospital, Shinkokai Medical Corporation

Division name

Department of Surgery

Zip code


Address

8-2-35, Shimoyamate-dori, Chuo-ku, Kobe City, Hyogo, 650-0011

TEL


Homepage URL


Email



Sponsor or person

Institute

Kuma Hospital, Shinkokai Medical Corporation

Institute

Department

Personal name



Funding Source

Organization

Covidien Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

2012 Year 01 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Completed

Date of protocol fixation

2011 Year 09 Month 09 Day

Date of IRB


Anticipated trial start date

2012 Year 01 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

2012 Year 01 Month 25 Day

Last modified on

2015 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007998


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name