Near Infrared Spectroscopy and Testicular Torsion in Children (SPIRETTE)

September 12, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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