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

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

Principal Investigator
Linda Baker

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. 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 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 withdrawl, 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 considered will be 750 subjects. no existing charts will be used in this prospective study.

Participant Eligibility

1. All males (one month of age to 21 years) who present to Children[Single Quote]s Medical Center Dallas (CMC) with acute scrotum from any ethnic background will be offered study participation.
2. Acute scrotum is defined as any male presenting with:
a. Painful acute scrotum or testes.
b. Abdominal pain (+/- nausea, vomiting).
c. Waddling gait (Cowboy shuffle
* ) from painful scrotum.