Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01812109 |
| Other study ID # |
STU 102010-133 |
| Secondary ID |
1R21DK092654-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 24, 2011 |
| Est. completion date |
November 9, 2015 |
Study information
| Verified date |
May 2024 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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. 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, we 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 privately so standard care
is not biased by NIRS data. Outcome variables will include NIRS StO2 ( percent oxygen
saturation) measurements, torsion status (yes/no), ultrasound parameters (testicular size,
volume, echogenicity, presence/absence of Doppler flow, whirlpool sign, hydrocele, scrotal
wall thickness), TWIST score variables, duration of pain, and duration of torsion. Study
endpoints will include early withdrawal, screen failures, orchiectomy for torsion, and 1-2
week or 3 month post-surgical follow-up (see Figure 1). 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.
At the surgeon's discretion, either a scrotal Doppler/B-mode ultrasound or emergent surgical
exploration will be planned as the next step per standard of care. While waiting for
preparation of either the scrotal Doppler/B-mode ultrasound or emergent surgical exploration,
the patient and guardian will be informed and invited for study participation. If they agree
to participate, they will be given a Fitzpatrick Skin Type (FST) Survey. This survey is a
classification scale that was created in 1975 for predicting skin reactivity in PUVA
(Psoralen plus ultraviolet A) photochemotherapy. [20] This survey asks the subject to grade
his tendency to burn and ability to tan respectively within 24 hours and 7 days after the
first un-protected sun-exposure in the early summer. There are four possible answers for
"white"-skinned persons (skin type I, II, II, IV). Brown skin classification is skin type V
and black skin classification is skin type VI. In the event that the survey has been missed,
we will mail a survey to the patient/guardian with a pre-stamped and addressed return
envelope. [20] 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. The NIRS measurements will not
bias the treatments performed or not performed on the study patients, permitting standard of
care treatment unbiased. The clinical data will be collected prospectively for each patient
utilizing REDCap Data Collection Management and stored in the REDCap databases and the
photographic database. Photographs will be taken of the scrotum. In addition, select
participants will be asked if they will allow us to videotape the NIRS measurements.
At the surgeon's decision and discretion, either a scrotal Doppler/B-mode ultrasound or
emergent surgical exploration will be planned as the next step per standard of care. While
waiting for this to occur, 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 scrotum on the left and right sides, immediately overlying the testis but on the
skin, to obtain the six total measurements. Thus, the unaffected testis will serve as the
patient's own control. NIRS #1 will not delay the scrotal Doppler/B-mode ultrasound or
emergent surgical exploration.
If the surgeon decides against surgical exploration, then standard care for the other causes
of acute scrotum will be provided and the diagnosis will be no testicular torsion. The
patient will be discharged home with a standard care follow-up in approximately two weeks in
an outpatient urology clinic appointment. The subject will be given a NIRS Daily Diary to
take home with them and record a five-day history of pain and recovery course. They will be
asked to bring this back at the two week follow-up visit.
If the scrotal Doppler/B-mode ultrasound identifies testicular torsion or if the surgeon
feels emergent surgical exploration is indicated, then emergent surgical exploration will be
performed. Photographs of the scrotum will be obtained, as well as select patients to be
consented for videotaping of the NIRS measurements At surgery under general anesthesia per
standard care, NIRS #2-4 will be performed. NIRS #2-4 is a series of 18 testicular tissue
measurements, nine on the affected testis and nine on the unaffected testis. Each testis will
receive nine measurements, three thru the skin and six directly on the exposed testis (three
prior to untwisting and three 5 minutes after untwisting). The probe will be laid on the
exposed testis (intraoperative testicular tissue). Each measurement is painless and takes <15
seconds each. The NIRS probe will be placed on the anterior testis to obtain the three sets
of three measurements. Thus, the unaffected testis will serve as the patient's own control.
NIRS #2-4 will not delay detorsion of the affected testis. Surgeons will be blinded to these
NIRS results, thus the decision during the operation will not be affected.
In addition, using a standardized color wheel we have created, the surgeon will be asked to
describe the color of the testis at the time of initial exposure and at 5 minutes after
detorsion.
If testicular torsion is found and the torsed testis is nonviable after detorsion, the
orchiectomy with contralateral orchiopexy will be performed per surgeon's decision. 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. One hour after the NIRS #2-4 measurements were
completed, NIRS #5 will be performed using the method described for NIRS #1 only on
postsurgical patients that underwent bilateral orchiopexy for testicular salvage.
At the time of discharge home, the subject will be given a NIRS Daily Diary to take home with
them and record a five-day history of pain and recovery course. They will be asked to bring
this back at the two week follow-up visit.
A phone interview will take place at day 5 to assess their postoperative pain course. A
telephone script will be utilized if the patients fail to follow-up with the urology clinic.
We will conduct this brief telephone interview with the parents/guardians as a means of
follow-up.
1-2 weeks 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 scrotal
Doppler/B-mode ultrasound will be obtained immediately and NIRS #6 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. In addition, photographs
of the scrotum and possible selected videotaping will be performed.
3. As per standard of care, if testicular torsion was present and the testis underwent
detorsion with orchiopexy, then NIRS #6 will be performed using the method described for
NIRS #1. At 3 months post-operatively, a scrotal Doppler/B-Mode Ultrasound will be
obtained to assess testicular volume and dimensions, which is standard of care follow-up
after orchiopexy. 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 #7 will be performed using the method described for NIRS #1,
photographs of the scrotum and possible selected videotaping will be performed. At that
time, the patient reaches study endpoint.
If the patient does not return at either the designated 1-2 weeks 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, 1-2 weeks 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.
