ICG in Paediatric Acute Scrotum
Research type
Research Study
Full title
Assessment of Diagnostic Accuracy of Indocyanine Green Fluorescence Imaging in Children and Young People with Testicular Pain Requiring Surgical Exploration
IRAS ID
1008108
Contact name
Caroline MacDonald
Contact email
Sponsor organisation
Sheffield Children's NHS Foundation Trust
ISRCTN Number
ISRCTN92614042
Research summary
Testicular torsion is a time critical condition for children and young people (CYP). It is difficult to diagnose without an operation. Missing it means the child will lose a testicle. There are no good diagnostic tests, only tests that delay the child’s journey to theatre, which puts them at further risk of losing the testicle. Most boys with a painful testicle get a surgical exploration to see if it is torsion and to untwist and fix it. Up to 85% of children having surgery will not have torsion. They will have something they didn’t need surgery for. We want to see whether a new, low risk, fast investigation could be used to diagnose the problem, meaning no torsions are missed and less children have unnecessary surgery. The research project will test ICG which is a fluorescent dye which shows flow or lack of flow in an organ. We hope it will be able to show the testes with absent blood flow to diagnose torsion, so no boys loose a testis in future. We hope it will show when there is a good blood supply preventing many hundreds of young men a year having an unnecessary operation. The benefits of the dye and camera system are huge. We are going to investigate whether ICG dye can safely diagnose torsion in a protocol which affects the child's normal pathway minimally and exposes them to almost no additional risk. When it is decided a child needs to go to theatre for a painful scrotum we will take a specialist camera photo after giving the dye (with no radiation exposure) and compare the findings of the photo with the outcome at surgery. This will allow us to test it it is safe and accurate.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
23/WM/0179
Date of REC Opinion
15 Nov 2023
REC opinion
Further Information Favourable Opinion