Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

描述（由申请方提供）：本研究的总体目标是改善睾丸扭转患者的护理。睾丸扭转是睾丸及其血管的自发性扭转。它影响至少1/4，000小于25岁的男性，主要见于新生儿或青少年男性。睾丸扭转引起急性剧烈疼痛，血管损害和死亡的睾丸，如果在6-8小时内发病。因此，通过快速手术复位（睾丸的手术解旋）进行快速、准确的诊断是必要的。不幸的是，诊断和治疗往往被延误，在30-70%的扭转病例中，死亡的睾丸被手术切除。 这种相对常见的问题是几种可能导致疼痛或“急性阴囊”的诊断之一，使临床诊断具有挑战性。虽然手术探查是证明扭转是否存在的金标准，但不必要的手术探查是不可取的。同样，睾丸超声与彩色多普勒，最常用的放射学检查，是89-97%的敏感性，但由于依赖于熟练的技术人员，减慢了评估的速度。由于只有6-8小时来挽救睾丸，这种诊断上的延误可能会降低挽救扭转睾丸的机会。需要新的灵敏和快速的方法来准确诊断扭转。 近红外光谱（NIRS）是一种简单的非侵入性技术，可评估身体深层组织的氧饱和度。它具有多种成人和儿童人类健康应用，但尚未在睾丸扭转中进行测试。我们建议评估这种方式在人类睾丸扭转的有用性。总体目标和具体目标是：1）评价NIRS在诊断睾丸扭转与其他原因引起的急性阴囊中的实用性，2）评估多普勒/B型超声与NIRS的敏感性和特异性，3）评价NIRS作为术中和术后测试预测手术复位后睾丸活力的实用性。 鉴于高安全性、测量速度、无创性、预计成本较低和高可用性以及无需熟练技术人员即可轻松执行，NIRS诊断睾丸扭转的创新应用可能会彻底改变并加速睾丸扭转患者的护理，从而可能挽救睾丸并减少不必要的手术。

DESCRIPTION (provided by applicant): The overall goal of this study is to improve the care of patients with testicular torsion. Testicular torsion is the spontaneous twisting of the testis and ts blood vessels. It affects at least 1 in 4,000 males younger than age 25 years and is primarily seen in the newborn or the adolescent male. Testicular torsion causes acute severe pain, vascular compromise and death of the testicle if unrelieved within 6-8 hours of onset. Thus, a rapid, accurate diagnosis with rapid surgical detorsion (surgical untwisting of the testis) is imperative. Unfortunately, diagnosis and treatment is often delayed and in 30-70% of torsion cases, the dead testis is surgically removed. This relatively common problem is one of several diagnoses that can cause a painful or "acute scrotum", making the clinical diagnosis challenging. While surgical exploration is the gold standard to prove whether torsion is present or absent, unnecessary surgical exploration is undesirable. As well, testicular ultrasound with color Doppler, the most commonly used radiological test, is 89-97% sensitive but slows the speed of the evaluation due to dependence upon a skilled technician. With only 6-8 hours to save the testis, this delay in diagnosis may decrease the chance of salvaging a torsed testis. New sensitive and rapid methods to accurately diagnose torsion are needed. 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. We 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 acut 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. Given the high safety profile, the speedof measurement, the non-invasive nature, the projected lower cost and high availability, and the ease of performance without a skilled technician, the innovative application of NIRS for diagnosing testicular torsion may revolutionize and accelerate the care of testicular torsion patients, potentially saving testes and decreasing unnecessary surgeries.