UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049327 |
|---|---|
| Receipt number | R000056172 |
| Scientific Title | Multi-institutional joint research to verify the effectiveness of an intestinal anastomosis simulator for very low birth weight infants in real clinical practice |
| Date of disclosure of the study information | 2022/10/26 |
| Last modified on | 2023/04/11 20:04:25 |
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Basic information
Public title
Multi-institutional joint research to verify the effectiveness of an intestinal anastomosis simulator for very low birth weight infants in real clinical practice
Acronym
Multi-institutional joint research to verify the effectiveness of an intestinal anastomosis simulator for very low birth weight infants in real clinical practice
Scientific Title
Multi-institutional joint research to verify the effectiveness of an intestinal anastomosis simulator for very low birth weight infants in real clinical practice
Scientific Title:Acronym
Multi-institutional joint research to verify the effectiveness of an intestinal anastomosis simulator for very low birth weight infants in real clinical practice
Region
| Japan |
Condition
Condition
Intestinal perforation in very low birth weight infants
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Participants practice intestinal anastomosis using the simulator under the guidance of instructors, and evaluate whether participants' actual surgical results improve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of surgical complications
Key secondary outcomes
Simulator results (required time, leak pressure after anastomosis)
Questionnaire survey for participants
Surgical results in real clinical practice (operating time, anastomosis time, period until establishment of oral intake, length of hospital stay)
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Participants practice the intestinal anastomosis procedure which takes about 1 hour each 6 times using the simulator under the guidance of the instructor.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pediatric surgeons who have not yet acquired "Shidou-i" of the Japanese Society of Pediatric Surgery, who works at research participating institutions
Key exclusion criteria
If consent is not obtained from the participant
If the participant cannot perform conventional anastomosis procedures due to injury or other reasons
When a participant moves to another institution during the training period
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takazawa |
Organization
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Division name
Department of Pediatric Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358008671
shinya.takazawa@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Takazawa |
Organization
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Division name
Department of Pediatric Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358008671
Homepage URL
shinya.takazawa@gmail.com
Sponsor or person
Institute
The University of Tokyo
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
Other related organizations
Co-sponsor
Gunma Children's Medical Center, University of Tsukuba Hospital, Kitasato University Hospital, Kyoto Prefectural University of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学、群馬小児医療センター、筑波大学附属病院、北里大学病院、京都府立医科大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 26 | 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
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056172
