Near Infrared Spectroscopy and Testicular Torsion in Children (SPIRETTE)

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

Study Overview

• Status: Completed
• Conditions: Child; Diagnosis; NIRS; Testicular Torsion; Diagnostic Test
• Intervention / Treatment: Other: near-infrared spectroscopy (NIRS)

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: testicular torsion	Other: near-infrared spectroscopy (NIRS); 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
Active Comparator: other testicular pathology	Other: near-infrared spectroscopy (NIRS); 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
Sham Comparator: healthy patients	Other: near-infrared spectroscopy (NIRS); 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Spermatic Cord Torsion
• Other Study ID Numbers: PI2019_843_0053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No