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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038551
Receipt No. R000043932
Scientific Title Multicenter study on surgical outcomes of transcanal endoscopic ear surgery (TEES) in Japan
Date of disclosure of the study information 2019/11/12
Last modified on 2020/06/18

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Basic information
Public title Multicenter study on surgical outcomes of transcanal endoscopic ear surgery (TEES) in Japan
Acronym Multicenter study on surgical outcomes of transcanal endoscopic ear surgery (TEES) in Japan
Scientific Title Multicenter study on surgical outcomes of transcanal endoscopic ear surgery (TEES) in Japan
Scientific Title:Acronym Multicenter study on surgical outcomes of transcanal endoscopic ear surgery (TEES) in Japan
Region
Japan

Condition
Condition middle ear diseases
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of TEES compared to a traditional microscopic ear surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative hearing outcomes
recurrence rate of cholesteatomas
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with middle ear diseases who underwent a primary surgery between 2017 and 2019
Key exclusion criteria patients with severe systemic complications
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Kakehata
Organization Yamagata University Faculty of Medicine
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code 990-9585
Address 2-2-2 Iida-Nishi, Yamagata-shi, Yamagata 990-9585, Japan
TEL 023-628-5380
Email seijik06@gmail.com

Public contact
Name of contact person
1st name Tsukasa
Middle name
Last name Ito
Organization Yamagata University Faculty of Medicine
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code 990-9585
Address 2-2-2 Iida-Nishi, Yamagata-shi, Yamagata 990-9585, Japan
TEL 023-628-5380
Homepage URL
Email tuito@med.id.yamagata-u.ac.jp

Sponsor
Institute Yamagata University
Institute
Department

Funding Source
Organization Yamagata University
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 IRB of Yamagata University Faculty of Medicine
Address 2-2-2 Iida-Nishi, Yamagata-shi, Yamagata 990-9585, Japan
Tel 023-628-5047
Email ikekenkyu@jm.kj.yamagata-u.ac.jp

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
2019 Year 11 Month 12 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 120
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 No longer recruiting
Date of protocol fixation
2018 Year 12 Month 10 Day
Date of IRB
2018 Year 12 Month 10 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Pre and postoperative evaluations for otoendoscopic findings, pure-tone audiometry, and CT scan findings at 6 months, 1, 2, 3 years after surgery.

Management information
Registered date
2019 Year 11 Month 12 Day
Last modified on
2020 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043932

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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