SPIRETTE: Near Infrared Spectroscopy and Testicular Torsion in Children

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05769244

Collaborator

(none)

Enrollment

Location

Arms

35.2

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Test NIRS Testicular Torsion Diagnosis Child	Other: near-infrared spectroscopy (NIRS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Near Infrared Spectroscopy and Testicular Torsion in Children

Actual Study Start Date :

Jun 24, 2020

Actual Primary Completion Date :

Jun 24, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05769244

Other Study ID Numbers:

PI2019_843_0053

First Posted:

Mar 15, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spermatic Cord Torsion

Study Results

No Results Posted as of Mar 20, 2023