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
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
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
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
