Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

Study ID
STU 102010-133

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Emma Sanchez
214/456-7974
emma.sanchez@childrens.com

Principal Investigator
Linda Baker

Official Title

Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

Brief Overview


Testicular torsion is the spontaneous twisting of the testis and its blood vessels,
resulting in acute pain, vascular compromise and death of the testicle if unrelieved
quickly. In this study, investigators will test a near-infrared spectroscopy (NIRS) device
that rapidly and non-invasively measures deep tissue oxygen saturation.

Summary


The main goal of this prospective, non-randomized pilot study is to assess the utility of
NIRS for the clinical diagnosis of the acute scrotum and testicular torsion. Near-Infrared
spectroscopy (NIRS) is a simple and non-invasive technique that assesses the oxygen
saturation of deeper body tissue. It has a variety of adult and pediatric human health
applications but has not been tested in testicular torsion. Investigators propose to
evaluate the usefulness of this modality in human testicular torsion. The overall objectives
and specific aims are: 1) To evaluate the utility of NIRS in the diagnosis of testicular
torsion versus other causes of the acute scrotum, 2) To assess the sensitivity and
specificity of Doppler/ B-mode Ultrasound versus NIRS, and 3) To evaluate the utility of
NIRS as an intraoperative and postoperative test for predicting testicular viability after
surgical detorsion.The sensitivity and specificity of NIRS for testicular torsion will be
defined relative to surgical exploration, scrotal Doppler/B-mode ultrasound, and clinical
follow-up. Last, investigators will assess the utility of intraoperative and postoperative
NIRS for predicting testicular viability after testicular detorsion. To achieve this,
standard care will be provided for all patients and at two or five time points NIRS
measurements will be obtained in a blinded fashion so standard care is not biased by NIRS
data. Outcome variables will include NIRS StO2 measurements, torsion status (yes/no),
ultrasound parameters (testicular size, volume, echogenicity, presence/absence of Doppler
flow, whirlpool sign, hydrocele, scrotal wall thickness) duration of pain, and duration of
torsion. Study endpoints will include early withdrawal, screen failures, orchiectomy for
torsion, and 1 week or 3 month post-surgical follow-up. In this 5 year single center study,
the maximum number of local subjects to be consented will be 750 subjects. No existing
charts will be used in this prospective study.

Patients with acute scrotum will be evaluated by history, physical examination, and
urinalysis per standard of care by staff in the ER, pediatric urology or pediatric surgery.
A gray scale/color Doppler testicular ultrasound or surgical exploration will be performed
as the next step per standard of care. While waiting for the next step, the patient and
guardian will be informed and invited for study participation. Those that refuse study
participation will receive standard of care treatment for the acute scrotum. Those that
accept study participation after informed consent will receive standard of care therapy for
the acute scrotum and will be evaluated by NIRS. At all time points in the study, the NIRS
measurements will be blinded to the researchers by the manufacturer's computer software and
placed in the NIRS database. Thus, the NIRS measurements will not bias clinical care,
permitting standard of care treatment unbiased. The clinical data collection sheet will be
completed prospectively for each patient (attachment) and entered into the non-NIRS
database.

While waiting for the gray scale/color Doppler testicular ultrasound or surgical
exploration, the NIRS #1 measurement will be obtained. NIRS #1 is a series of 6
transcutaneous scrotal measurements, three on the left and three on the right. Each
measurement is completely non-invasive, painless and takes ~15 seconds each. Thus, no
sedation or supplemental analgesia will be needed for NIRS. The NIRS probe will be placed on
the anterior, lateral and posterior scrotum on the left and right sides, immediately
overlying and parallel to the long axis of the testis but on the skin, to obtain the six
total measurements. Thus, the unaffected testis will serve as the patient's own control. In
this study, the study coordinators will be performing the ER transscrotal NIRS testing. To
achieve uniform testing, all will be trained for testicular probe placement methods. NIRS #1
will not delay the gray scale/color Doppler testicular ultrasound or surgery.

If the surgeon decides against surgical exploration, then standard care for the other causes
of acute scrotum will be provided, the diagnosis will be no testicular torsion and the
patient will be discharged home with a standard care 1 week follow-up outpatient urology
clinic appointment.

If the gray scale/color Doppler testicular ultrasound identifies testicular torsion, then
emergent surgical exploration will be performed. At surgery under general anesthesia per
standard care, NIRS #2 will be performed. NIRS #2 is a series of 9 testicular tissue
measurements performed sterile, six on the affected testis and three on the unaffected
testis. The affected testis will receive six measurements because the first set of three
will be immediately when the testis is exposed and still with testicular torsion while the
second set of three measurements will be 5 minutes after the testis was detorsed. NIRS #1
and NIRS #2 measurements are different; NIRS #1 measurements are of the testis through the
scrotal skin (transcutaneous) while NIRS #2 measurements are not through the skin but are
directly obtained on the exposed testis without testicular puncture. The probe will be laid
on the exposed testis intraoperative testicular tissue) after the scrotum has been
surgically opened. Each measurement is painless and takes ~15 seconds each. The NIRS probe
will be placed on the anterior, lateral and posterior testis to obtain the three sets of
three measurements. Thus, the unaffected testis will serve as the patient's own control.
NIRS #2 will not delay the detorsion of the affected testis. Surgeons will be blinded to
these NIRS results by the same special software as well, thus the decision during the
operation will not be affected. If testicular torsion is found and the detorsed testis is
deemed nonviable, the orchiectomy with contralateral orchiopexy will be performed. The
patient will be discharged home and will reach study endpoint. If testicular torsion is
found and the torsed testis is viable after detorsion, then bilateral orchiopexy will be
performed as is standard. One hour after the NIRS #2 measurements were completed, NIRS #3
will be performed using the method described for NIRS #1 only on postsurgical patients that
went bilateral orchiopexy for testicular salvage.

One week later, non-surgical patients and surgical patients having bilateral orchiopexy will
return for an outpatient urology clinic evaluation of ~1 hour duration.

1. After standard care clinical evaluation, if the diagnosis is still no testicular
torsion, then the patient is discharged home and reaches study endpoint.

2. After standard care clinical evaluation, if there is a clinical concern over testicular
viability (missed testicular torsion), then a repeat standard care gray scale/color
Doppler testicular ultrasound will be obtained immediately and NIRS #4 will be
performed using the method described for NIRS #1. The patient will be categorized as
torsion or no torsion based on clinical findings and reaches study endpoint.

3. As per standard of care, if testicular torsion was present and the testis underwent
detorsion with orchiopexy, then NIRS #4 will be performed using the method described
for NIRS #1. At 3 months postoperatively, a gray scale/color Doppler testicular
ultrasound will be obtained to assess testicular volume and dimensions. The affected
testis will be categorized as normal, <20% testicular volume loss, 20-50% volume loss,
or >50% volume loss based on ultrasound parameters. At that ~1 hour visit, NIRS #5 will
be performed using the method described for NIRS #1 and the patient reaches study
endpoint.

If the patient does not return at the designated one week or three month follow-up
outpatient urology clinic evaluation, then the PI and/or research nurse coordinator will
telephone the guardian to encourage return to clinic and for verbal status report on the
child's clinical state.

Thus the total number of study visits, including the presenting emergency visit, is three
(Emergency, 1 week post-operatively, and 3 months post-operatively). No medications will be
administered in this study. No blood or tissue will be collected and no radiation exposure
or questionnaires will be given. No subjects will be responsible for any research-related
costs; however, they will be responsible for standard care costs. At the end of the study,
standard care will be turned over to the primary care physician or pediatric urologist if
needed. No sub-study procedures will be performed.

Participant Eligibility


Inclusion Criteria:

Males one month to 21 years of age with:

Painful acute scrotum or testis OR Abdominal pain (+/- nausea, vomiting) and waddling gait
("cowboy shuffle") from painful scrotum.

Exclusion Criteria:

Males with:

Synchronous bilateral testicular torsion History of known testicular or scrotal surgery
Current hernia or painless hydrocele Current obvious scrotal bug bites History of chronic
respiratory, hematological or vascular problems that will affect total body tissue
oxygenation levels (Home oxygen).