Tokyo, March 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060913) titled 'Usefulness of indocyanine green fluorescence imaging for evaluating testicular blood flow in pediatric testicular torsion' on March 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Juntendo University

Condition: Condition - testicular torsion Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the usefulness of objectively assessing testicular blood flow using indocyanine green ICG fluorescence imaging during emergency surgery for pediatric testicular torsion. Traditionally the decision to preserve or remove the testis has depended on the surgeons macroscopic findings and clinical experience. By introducing ICG based blood flow assessment this study seeks to determine whether the degree of testicular ischemia can be evaluated more objectively and whether more appropriate intraoperative treatment decisions can be made. Outcomes will be compared with those of conventional management without ICG to clarify whether the use of ICG improves the success rate of testicular preservation and reduces unnecessary orchiectomy and reoperations. Furthermore pathological re evaluation of removed testes will be performed to assess the appropriateness of intraoperative surgical judgment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Indocyanine Green (ICG)

Eligibility: Age-lower limit - Not applicable Age-upper limit - 16 years-old > Gender - Male Key inclusion criteria - 1 Subjects aged 0 years or older and younger than 16 years at the time of obtaining consent

2 Subjects who received sufficient explanation regarding participation in this study and from whom written informed consent was obtained based on the free will of the subject or the subjects guardian after adequate understanding Key exclusion criteria - 1 Cases judged to be inappropriate for inclusion by the operating surgeon even if consent from the subject and the subjects family has been obtained

2 Patients judged to be inappropriate as study subjects by the principal investigator for other reasons Target Size - 15

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2022 Year 06 Month 01 Day Date of IRB - 2022 Year 09 Month 16 Day Anticipated trial start date - 2022 Year 09 Month 15 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069712

Disclaimer: Curated by HT Syndication.