Near Infrared Spectroscopy and Testicular Torsion in Children

Not Applicable

Completed

• Conditions: NIRS; Diagnostic Test; Child; Testicular Torsion; Diagnosis
• Interventions: Other: near-infrared spectroscopy (NIRS)

• Registration Number: NCT05769244
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-24
• Primary Completion: 2022-06-24
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Status Verified: 2023-09
• Study Completion: 2023-09-12
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy patients	near-infrared spectroscopy (NIRS)	-
testicular torsion	near-infrared spectroscopy (NIRS)	-
other testicular pathology	near-infrared spectroscopy (NIRS)	-

Primary Outcome Measures

Name	Time	Method
mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain	one day	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
mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal pain	one day	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
mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boys	one day	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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France