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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041092
Receipt No. R000046920
Scientific Title Real-time assessment of flap and dental area tissue capillary circulation using video-capillaroscopy
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/21

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Basic information
Public title Real-time assessment of flap and dental area tissue capillary circulation using video-capillaroscopy
Acronym Real-time assessment of capillary circulation using video-capillaroscopy
Scientific Title Real-time assessment of flap and dental area tissue capillary circulation using video-capillaroscopy
Scientific Title:Acronym Real-time assessment of capillary circulation using video-capillaroscopy
Region
Japan

Condition
Condition Head and neck cancer, mandibula osteonecrosis, mandibula and maxilla deformity, benign head and neck tumor
Classification by specialty
Dermatology Oto-rhino-laryngology Oral surgery
Plastic surgery Aesthetic surgery Operative medicine
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Blood flow of free or pedicled flap for reconstruction after head and neck tumor resection and gingiva and jaw bone blood flow in surgery is observed minimally invasively using video-capillaroscopy, and perform appropriate surface blood flow evaluation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Measurement of blood flow velocity and vasodilatation in video recorded by video-capillaroscopy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 The artery and vein of the free flap are clamped for about 2 minutes (per surgery) and then capillary blood flow of the flap skin surface is observed.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients requiring surgery for the treatment of head and neck cancer, osteonecrosis of the jaw, jaw deformity, and benign tumor of the head and neck
Key exclusion criteria (1) who are under 15 years old
(2) without written consent
(3) who are not going to have surgical treatment
(4) who are not considered eligible to participate in this study by the attending doctor due to other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takakuni
Middle name
Last name Tanaka
Organization Toyooka Public Hospital
Division name Oral and Maxillofacial surgery
Zip code 668-8501
Address 1094 Tobera, Toyooka-city, Hyogo, Japan
TEL (0796)22-6111
Email tanat222@yahoo.co.jp

Public contact
Name of contact person
1st name Takakuni
Middle name
Last name Tanaka
Organization Toyooka Public Hospital
Division name Oral and Maxillofacial surgery
Zip code 668-8501
Address 1094 Tobera, Toyooka-city, Hyogo, Japan
TEL (0796)22-6111
Homepage URL
Email tanat222@yahoo.co.jp

Sponsor
Institute Toyooka Public Hospital
Institute
Department

Funding Source
Organization Toyooka Public Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Toyooka Public Hospital Clinical Study Review Board
Address 1094 Tobera, Toyooka-city, Hyogo, Japan
Tel (0796)22-6111
Email kanri.toyooka@toyookahp-kumiai.or.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
2020 Year 07 Month 13 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 Open public recruiting
Date of protocol fixation
2020 Year 07 Month 13 Day
Date of IRB
2020 Year 07 Month 20 Day
Anticipated trial start date
2020 Year 07 Month 13 Day
Last follow-up date
2025 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This experiment includes a retrospective observational study and a prospective intervention study. As a preliminary step, with respect to the free flap elevated during the surgery, the artery and vein were clamped for about 1 minute to confirm the blood flow on the flap surface was observed by Video capillaroscopy. The blood flow was evaluated, and after confirming that there was good blood circulation of the flap capillaries, the flap was transplanted to the defect due to tumor or necrosis resection.
We plan to design a prospective intervention study based on this retrospective observational study data, then collect and analyze the data after July 13, 2020.

Management information
Registered date
2020 Year 07 Month 13 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046920

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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