UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044346
Receipt number R000050635
Scientific Title Development of a surgical support and education system for laparoscopic surgery using intraoperative Holograms and gaze presentation function with Mixed-Reality technology
Date of disclosure of the study information 2021/05/27
Last modified on 2021/12/01 11:06:47

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Development of a surgical support and education system for laparoscopic surgery using intraoperative Holograms and gaze presentation function with Mixed-Reality technology

Acronym

Development of a surgical support and education system for laparoscopic surgery using intraoperative Holograms and gaze presentation function with Mixed-Reality technology

Scientific Title

Development of a surgical support and education system for laparoscopic surgery using intraoperative Holograms and gaze presentation function with Mixed-Reality technology

Scientific Title:Acronym

Development of a surgical support and education system for laparoscopic surgery using intraoperative Holograms and gaze presentation function with Mixed-Reality technology

Region

Japan


Condition

Condition

cholecystitis, choleilithiasis

Classification by specialty

Hepato-biliary-pancreatic surgery Operative medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety and efficacy of laparoscopic cholecystectomy using holography-guided navigation system as an intraoperative support image.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Operation time,Blood loss,perioperative complication rate

Key secondary outcomes

Questionnaire and NASA Task Load Index for surgeons.


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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with cholelithiasis or grade1 acute cholecystitis according to the Tokyo Guideline2018.
Patients underwent four-port laparoscopic cholecystectomy.
Body mass index less than 25
American Society of Anethesiologists preoperative status classification(ASA-PS)2 or less.
No previous upper abdominal surgery.
Positive results of the gallbladder,cystic duct and common bile duct on prepoperative drip infusion cholangiography with computed tomography(DIC-CT).
No thickening of the gallbladder wall or enlargement of the gallbladder due to inflammation on preoperative imaging.
Patients who gained written consent by the patient's free will with sufficient understanding after receiving sufficient explanation for participation of this study.

Key exclusion criteria

Patients underwent percutaneous transhepatic gallbladder drainage or percutaneous transhepatic gallbladder aspiration.
Patients diagnosed with Mirizzi syndrome.
Atrophic gallbladder.
Patients diagnosed with choledocholithiasis or underwent endoscopic sphincterotomy.
Patients with an allergy to contrast media.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Michiko
Middle name
Last name Kitagawa

Organization

Yotsuya Medical Cube

Division name

Minimally Invasive Surgery Center, Surgery Endoscope Surgeon

Zip code

102-0084

Address

7-7 Nibancho,Chiyoda-ku,Tokyo

TEL

03-3261-0401

Email

m-kitagawa@mcube.jp


Public contact

Name of contact person

1st name Michiko
Middle name
Last name Kitagawa

Organization

Yotsuya medical Cube

Division name

Minimally Invasive Surgery Center

Zip code

102-0084

Address

7-7 Nibancho, Chiyoda-ku,Tokyo

TEL

03-3261-0401

Homepage URL


Email

m-kitagawa@mcube.jp


Sponsor or person

Institute

Yotsuya Medical Cube

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

The Japanese foundation for research and promotion endoscopy


IRB Contact (For public release)

Organization

Division for clinical research management, Yotsuya Medical Cube

Address

7-7 Nibancho, Chiyoda-ku, Tokyo

Tel

03-3261-0401

Email

h-sato@mcube.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

2021 Year 05 Month 27 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.surgjournal.com/article/S0039-6060(21)00962-4/fulltext

Number of participants that the trial has enrolled

27

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 09 Month 20 Day

Date of IRB

2019 Year 09 Month 20 Day

Anticipated trial start date

2020 Year 04 Month 02 Day

Last follow-up date

2021 Year 11 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: Prospective observational study


The purpose of this study is to assess the safety and efficacy of laparoscopic cholecystectomy using a wearable mixed-reality device as an intraoperative support image by comparing conventional 2D images with 3D models.


Management information

Registered date

2021 Year 05 Month 27 Day

Last modified on

2021 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050635


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/06/14 レポジトリデータ.xlsx