UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041092 |
|---|---|
| Receipt number | 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 12:31:58 |
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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
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
tanat222@yahoo.co.jp
Sponsor or person
Institute
Toyooka Public Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046920
