Evaluation of the Learning Curve for the Visualization of Sacral Nerve Roots and Sacral Plexus on Gynecological Transvaginal Ultrasound - PlexUS Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- The number of scans to gain competency for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound
研究概览
简要总结
The purpose of this prospective study was to evaluate the learning curve of TVUS (transvaginal ultrasound) for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound. The investigators aim to evaluate to evaluate the number needed to gain competence or to review the level of competence.
详细描述
For each patient, the fellows are blinded to the clinical and surgical history. The investigators will be aware that all patients were being evaluated for pelvic pain or endometriosis. The expert sonographer assess the patient and visualized the sacral roots and the sacral plexus first as part of the advanced TVUS examination for endometriosis.
TVUS examination will conducted in six steps eas follows in six successive steps. All women will be asked to empty their bladder prior to examination. TVUS scans will be performed in the lithotomy position in a standardized fashion using a transvaginal probe Step 1: First the probe will inserted into the anterior vaginal fornix. The uterus is examined in the midsagittal view on the longitudinal section to identify the cervix and the uterine cavity. The image is frozen with time displayed on the screen, which was marked as Time 1.
Step 2: The image is unfrozen and at the level of the inner cervical meatus the transducer is rotated 90 degrees counterclockwise to obtain a transverse scan.
Step 3: Then the probe is immediately moved towards the right lateral fornix pointing towards the uterine vessels, which appear as hypoechoic bands. Behind these structures, a thick hyperechoic band - the left uterosacral ligament -appears, starting from the cervix and pointing laterally in a semi horizontal direction. By rotating the probe the uterosacral ligament is then followed from medial to lateral, up to the lateral pelvic wall. The obturator internus muscle covers most of the lateral wall of the pelvis minor, which - in transverse scan - is a hypoechoic thin band just lateral to the uterosacral ligament. On the lateral side of the muscle a continuous bright white band is seen, corresponding to the body of the ischium.
Step 4: Sweeping the probe medially and pushing it superior the hypoechoic obturator internus muscle and the hyperechoic ischium are followed ending at the greater sciatic foramen. At this point transverse and oblique sections of the branches of the anterior division of the internal iliac vessels became visible. Deeper to the vessels the hypoechoic muscle fiber bundles with intervening echogenic perimysium, the piriformis muscle, and a bright white line, the anterior surface of the sacrum are visualized. Between the vessels and the piriformis muscle on conventional gray scale B mode the sacral roots of the sacral plexus (SP) appear in longitudinal section, with a typical "bundle of straw" appearance: hypoechoic bands, with echogenic septae. The hypoechoic areas correspond to nerve fascicles, while the hyperechoic septae correspond to the inner and outer epineurium. In transverse section, the nerves have a "honeycomb" shape echotexture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with pelvic pain scheduled for TVS
排除标准
- •Women who have never been sexually active
- •(suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy
- •Premenarche
- •Pregnancy
- •Patients refusal to participate to the study
结局指标
主要结局
The number of scans to gain competency for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound
时间窗: 12 months
The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate.
次要结局
- differences between participating centers.(12 months)
- differences between sonographers of different level of experience in the field of gynecological TVS.(12 months)
- inter and intraobserver variability(12 months)
