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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039071
Receipt No. R000044562
Scientific Title Comparison of outcomes after thyroid cancer surgery performed with and without energy devices
Date of disclosure of the study information 2020/01/07
Last modified on 2020/01/07

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Basic information
Public title Comparison of outcomes after thyroid cancer surgery performed with and without energy devices
Acronym Comparison of outcomes after thyroid cancer surgery performed with and without energy devices
Scientific Title Comparison of outcomes after thyroid cancer surgery performed with and without energy devices
Scientific Title:Acronym Comparison of outcomes after thyroid cancer surgery performed with and without energy devices
Region
Japan

Condition
Condition thyroid cancer
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aimed to evaluate the benefits of using energy devices (ED) for thyroid cancer surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the occurrence of postoperative complications
Key secondary outcomes duration of anesthesia, length of stay, total costs, in-hospital mortality, and 30-day readmission rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Using a Japanese national inpatient database, we identified patients with thyroid cancer who underwent thyroidectomy from July 2010 to March 2017.
Key exclusion criteria We excluded patients whose preoperative diagnosis was poorly differentiated thyroid carcinoma, anaplastic thyroid carcinoma, or malignant lymphoma, patients who also had Graves' disease or Hashimoto disease, and patients who underwent another operation for conditions other than complications of thyroidectomy during the hospitalization.
Target sample size 50000

Research contact person
Name of lead principal investigator
1st name Takaaki
Middle name
Last name Konishi
Organization The University of Tokyo
Division name Department of Breast and Endocrine Surgery, Graduate School of Medicine
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-1887
Email takaakonishi-ncd@umin.ac.jp

Public contact
Name of contact person
1st name Takaaki
Middle name
Last name Konishi
Organization The University of Tokyo
Division name Department of Breast and Endocrine Surgery, Graduate School of Medicine
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-1887
Homepage URL
Email takaakonishi-ncd@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NA
Address NA
Tel NA
Email NA

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
2020 Year 01 Month 07 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 59394
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
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 05 Month 01 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This nationwide retrospective cohort study was performed using the Diagnosis Procedure Combination database, which includes hospital administrative claims data and discharge abstracts of approximately 7,000,000 inpatients in more than 1000 hospitals throughout Japan [26, 27], covering approximately half of all inpatient admissions to acute-care hospitals in Japan. All 82 university hospitals are obliged to participate in the database; participation by community hospitals is voluntary.

Management information
Registered date
2020 Year 01 Month 07 Day
Last modified on
2020 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044562

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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