testicular torsion
Conditions
Interventions
Indocyanine Green (ICG)
Sponsors
Juntendo University
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The outcomes of this study will be evaluated by assessing the presence or absence of testicular blood flow intraoperatively using indocyanine green ICG fluorescence imaging and determining whether the affected testis could be preserved. The ICG based perfusion assessment will be compared with the surgeons conventional macroscopic intraoperative evaluation to analyze any concordance or discrepancy in the decision to preserve or remove the testis. In addition the postoperative course of preserved testes will be followed to assess the occurrence of testicular atrophy and to determine whether ICG based blood flow evaluation contributes to more appropriate decisions regarding testicular preservation. Furthermore histopathological evaluation of removed testes will be performed to verify the appropriateness of the intraoperative surgical judgment. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary outcome, testes preserved based on intraoperative assessment will be followed for two years after surgery. During the follow-up period, periodic ultrasonographic examinations will be performed to evaluate the presence and adequacy of intratesticular blood flow, as well as changes in testicular volume. These assessments will be used to determine whether adequate perfusion is maintained and whether testicular atrophy occurs in the preserved testes, thereby allowing evaluation of the appropriateness of the intraoperative blood flow assessment and the decision to preserve the testis. | — |
Countries
Japan
Contacts
Public ContactHisae Iida
Juntendo University Hospital Pediatric Surgery
Outcome results
None listed