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 |
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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
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
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
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
