Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059919) titled 'Evaluation of the Educational Effectiveness of a Non-Technical Skills Training System in Laparoscopic Inguinal Hernia Repair' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Faculty of Medicine, Graduate School of Medicine, Hokkaido University

Condition: Condition - Inguinal hernia Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 18

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 28 Day Anticipated trial start date - 2025 Year 12 Month 05 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068527

Disclaimer: Curated by HT Syndication.