Near Infrared Spectroscopy and Testicular Torsion in Children (SPIRETTE)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Child; Diagnostic Test; Diagnosis; Testicular Torsion; NIRS

Treatments: Other: near-infrared spectroscopy (NIRS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05769244

PI2019_843_0053

Details and patient eligibility

About

NIRS estimates tissue saturation of oxygenation in tissue beds. Animals studies suggested that transscrotal NIRS measurements can quantify testicular hypoxia and differentiate between torsed and non torsed testicles. The results of human studies are not conclusive. The hypothesis is that the difference in NIRS values between torsed and healthy testicles would not be zero and that this difference would be zero in control group and that NIRS could help to detect rapidly a TT Testicular torsion (TT) is a functional emergency. The diagnosis is sometimes difficult to make. No paraclinical examination can eliminate it with certainty. The investigators aimed to evaluate the interest of transscrotal near-infrared spectroscopy (NIRS) for the diagnosis of TT of child

Enrollment: 55 patients

Sex: Male

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Step 1: healthy boys between 0 and 16 years old
• Step 2Testicular pain group (Group 1 and 2): boy under 18 years, testicular pain

Exclusion criteria

• cutaneous scrotal lesion,
• fever (for the control group),
• hypertension

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups

testicular torsion

Experimental group

Treatment:

Other: near-infrared spectroscopy (NIRS)

other testicular pathology

Active Comparator group

Treatment:

Other: near-infrared spectroscopy (NIRS)

healthy patients

Sham Comparator group

Treatment:

Other: near-infrared spectroscopy (NIRS)