Near Infrared Spectroscopy and Testicular Torsion in Children

NCT ID: NCT05769244

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2023-09-12

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

Detailed Description

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Conditions

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Diagnostic Test NIRS Testicular Torsion Diagnosis Child

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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testicular torsion

Group Type EXPERIMENTAL

near-infrared spectroscopy (NIRS)

Intervention Type OTHER

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

other testicular pathology

Group Type ACTIVE_COMPARATOR

near-infrared spectroscopy (NIRS)

Intervention Type OTHER

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

healthy patients

Group Type SHAM_COMPARATOR

near-infrared spectroscopy (NIRS)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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
Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2019_843_0053

Identifier Type: -

Identifier Source: org_study_id

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