UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Clinical Trial of Ligasure Small Jaw versus conventional thyroidectomy for Graves' disease
Title of the study (Brief title)	Randomized Clinical Trial of Ligasure Small Jaw versus conventional thyroidectomy for Graves' disease
Region	Japan

Condition
Condition	Graves' disease
Classification by specialty	Endocrine surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of LigaSure small jaw vessel sealing system in surgery for Graves' disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Operation time
Key secondary outcomes	Blood loss, drain output, complications (post-operative hemorrhage, recurrent laryngeal nerve paralysis, hypoparathyroidism ), number of sutures used

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Graves' disease 2)Preserved major organ function 3)Patients providing written informed consent for participation in the study
Key exclusion criteria	1)History of neck surgery 2)Requiring neck lymph node dissection 3)Without Graves' disease 4)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	Akifumi Suzuki
Organization	Ito Hospital
Division name	Surgery
Address	4-3-6, Jingumae, shibuya-ku, Tokyo, Japan, 150-8308
TEL	03-3402-7411
Email	af-suzuki@ito-hospital.jp

Public contact
Name of contact person	Akifumi Suzuki
Organization	Ito Hospital
Division name	Surgery
Address	4-3-6, Jingumae, shibuya-ku, Tokyo, Japan, 150-8308
TEL	03-3402-7411
Homepage URL
Email	af-suzuki@ito-hospital.jp

Sponsor
Institute	Ito Hospital
Institute
Department

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)

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	2014 Year 03 Month 23 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 09 Month 30 Day
Date trial data considered complete	2015 Year 09 Month 30 Day
Date analysis concluded	2015 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 23 Day
Last modified on	2016 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015753