UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Measurement of blood flow velocity and vasodilatation in video recorded by video-capillaroscopy

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Toyooka Public Hospital

Institute

Department

Personal name

Organization

Toyooka Public Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

07

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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