Near Infrared Spectroscopy and Testicular Torsion in Children

Study Overview
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Brief Summary
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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

Official Title
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Near Infrared Spectroscopy and Testicular Torsion in Children

Conditions
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Diagnostic Test, NIRS, Testicular Torsion, Diagnosis, Child

Intervention / Treatment
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* Other: near-infrared spectroscopy (NIRS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testicular torsion<br> | Other: near-infrared spectroscopy (NIRS)<br>* NIRS measurements will be performed on each testicle on a group of healthy boys and on a group of boys under 18 years consulting to emergency for scrotal pain<br>|
| Active Comparator: other testicular pathology<br> | Other: near-infrared spectroscopy (NIRS)<br>* NIRS measurements will be performed on each testicle on a group of healthy boys and on a group of boys under 18 years consulting to emergency for scrotal pain<br>|
| Sham Comparator: healthy patients<br> | Other: near-infrared spectroscopy (NIRS)<br>* NIRS measurements will be performed on each testicle on a group of healthy boys and on a group of boys under 18 years consulting to emergency for scrotal pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boys | Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients | one day | 
| mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain | Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients | one day | 
| mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal pain | Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients | one day |