UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055466 |
|---|---|
| Receipt number | R000063355 |
| Scientific Title | A Non-Randomized Controlled Trial to Assess the Safety of Robotic Surgery Performed by Young Pediatric Surgeons |
| Date of disclosure of the study information | 2024/09/10 |
| Last modified on | 2024/09/09 20:03:56 |
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Basic information
Public title
A Non-Randomized Controlled Trial to Assess the Safety of Robotic Surgery Performed by Young Pediatric Surgeons
Acronym
A Non-Randomized Controlled Trial to Assess the Safety of Robotic Surgery Performed by Young Pediatric Surgeons
Scientific Title
A Non-Randomized Controlled Trial to Assess the Safety of Robotic Surgery Performed by Young Pediatric Surgeons
Scientific Title:Acronym
A Non-Randomized Controlled Trial to Assess the Safety of Robotic Surgery Performed by Young Pediatric Surgeons
Region
| Japan |
Condition
Condition
congenital biliary dilatation
Classification by specialty
| Hepato-biliary-pancreatic surgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to ascertain whether young pediatric surgeons can safely perform robotic surgery for congenital biliary dilatation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of postoperative adverse events (Clavien-Dindo classification III or higher)
Key secondary outcomes
Operating time, blood loss, postoperative hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Young pediatric surgeons who are not board certified in pediatric surgery will perform the surgery under the supervision of a robotic surgical proctor.
Interventions/Control_2
Certified pediatric surgeons will perform the surgery.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing robotic surgery for congenital biliary dilatation at the Department of Pediatric Surgery, Nagoya University Hospital.
Key exclusion criteria
Excludes perforated cases or cases weighing less than 10kg.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Ota |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of pediatric surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527412111
ota.kazuki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Ota |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of pediatric surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527412111
Homepage URL
ota.kazuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
0527412111
ota.kazuki@med.nagoya-u.ac.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
| 2024 | Year | 09 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2038 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063355
