Is ICG imaging safe and accurate to predict testicular torsion?

Phase 2

• Conditions: Acute scrotum; Urological and Genital Diseases

• Registration Number: ISRCTN92614042
• Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-04
• Last Update Posted: 29 January 2024
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 107

Inclusion Criteria

1. Children presenting with testicular pain being taken to theatre for scrotal exploration at Sheffield Children's NHS Foundation Trust
2. Aged 0-19 years

Exclusion Criteria

Children with any allergy to contrast medium or iodine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis, will be calculated by findings of fluorescence versus non-fluorescence compared to surgical outcomes of salvage versus non salvage at surgery

Secondary Outcome Measures

Name	Time	Method
<br> 1. ICG diagnostic accuracy by tanner stage and skin pigmentation will be calculated by findings of fluorescence versus non-fluorescence compared to surgical outcomes of salvage versus non salvage at surgery<br> 2. ICG to predict late testicular atrophy will be calculated by findings of fluorescence versus non-fluorescence compared to surgical outcomes of salvage versus non salvage at 12 month clinical review<br> 3. Adverse reactions from ICG injection measured using SUSAR reporting for inpatient course<br> 4. Family and CYP acceptance of diagnostic procedure measured using survey and qualitative methodology<br>