UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059919 |
|---|---|
| Receipt number | R000068527 |
| Scientific Title | Evaluation of the Educational Effectiveness of a Non-Technical Skills Training System in Laparoscopic Inguinal Hernia Repair (Transabdominal Preperitoneal approach) |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/28 15:51:03 |
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Basic information
Public title
Evaluation of the Educational Effectiveness of a Non-Technical Skills Training System in Laparoscopic Inguinal Hernia Repair
Acronym
Evaluation of the Educational Effectiveness of a Non-Technical Skills Training System in Laparoscopic Inguinal Hernia Repair
Scientific Title
Evaluation of the Educational Effectiveness of a Non-Technical Skills Training System in Laparoscopic Inguinal Hernia Repair (Transabdominal Preperitoneal approach)
Scientific Title:Acronym
Evaluation of the Educational Effectiveness of a Non-Technical Skills Training System in Laparoscopic Inguinal Hernia Repair (Transabdominal Preperitoneal approach)
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Educational Impact of Assessment and Feedback Using KUDAS-TAPP, a Non-Technical Skills Assessment Tool Developed for TAPP Procedures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GOALS-GH score, an objective assessment metric for TAPP
Key secondary outcomes
KUDAS-TAPP score
TAPPchecklist score, other objective assessment metric for TAPP
operative time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
An interview with the operating surgeon will be conducted within two days after each TAPP procedure, during which the surgeon will be evaluated using the KUDAS-TAPP and GOALS-GH scales.
In the intervention group, in addition to the usual instruction provided at each institution, approximately 30 minutes of feedback will be delivered. The feedback will be provided by the interviewer using feedback materials developed based on the items of the KUDAS-TAPP.
A re-evaluation will be conducted for the next TAPP procedure performed at least six weeks after the feedback session, in order to assess the sustainability of the educational effect.
Interventions/Control_2
An interview with the operating surgeon will be conducted within two days after each TAPP procedure, during which the surgeon will be evaluated using the KUDAS-TAPP and GOALS-GH scales.
In the control group, no feedback will be provided; surgeons will continue to receive the standard instruction at their respective institutions.
After completion of the second interview, the control group will receive the same feedback session, and their subsequent operation will be evaluated in the same manner.
A re-evaluation will be conducted for the next TAPP procedure performed at least six weeks after the feedback session, in order to assess the sustainability of the educational effect.
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
Surgeons
Individuals who, after receiving a full explanation of the study, have provided written informed consent based on sufficient understanding and of their own free will.
Surgeons who regularly perform laparoscopic inguinal hernia repair at their institution.
Surgeons within 10 years of post-graduate experience (or an equivalent level of clinical experience as a surgeon).
Patients
Individuals who, after receiving a full explanation of the study, have provided written informed consent based on sufficient understanding and of their own free will.
Key exclusion criteria
Surgeons who, at the time of their initial procedure, achieve a KUDAS-TAPP score of 48 or higher and a GOALS-GH score of 14 or higher.
Individuals whom the principal investigator deems inappropriate as study participants.
Patients undergoing emergency surgery, incarceration cases, or recurrent cases in which the procedure deviates from the standard TAPP technique.
Individuals whom the principal investigator deems inappropriate as study participants.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hirano |
Organization
Faculty of Medicine, Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterological Surgery II
Zip code
060-8638
Address
Kita15 Nishi 7, Kita-ku, Sapporo city, Hokkaido
TEL
0117067714
satto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Akitaka |
| Middle name | |
| Last name | Motoyoshi |
Organization
Faculty of Medicine, Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterological Surgery II
Zip code
060-8638
Address
Kita15 Nishi 7, Kita-ku, Sapporo city, Hokkaido
TEL
0117067714
Homepage URL
kyokui130107@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University IRB
Address
Kita14 Nishi5, Kita-ku, Sapporo city
Tel
0117161161
crjimu@huhp.hokudai.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
北海道大学病院(北海道)、手稲渓仁会病院(北海道)、旭川赤十字病院(北海道)、北見赤十字病院(北海道)、北海道消化器科病院(北海道)、製鉄記念室蘭病院(北海道)、名寄市立病院(北海道)、旭川厚生病院(北海道)、小樽市立病院(北海道)、独立行政法人地域医療機能推進機構北海道病院(北海道)、天使病院(北海道)、江別病院(北海道)、砂川市立病院(北海道)、市立函館病院(北海道)、釧路労災病院(北海道)、遠軽厚生病院(北海道)、小林病院(北海道)、岩見沢市立総合病院(北海道)、尾道総合病院(広島県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | 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
| 2025 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 05 | 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
| 2025 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068527
