Department of Obstetrics and Gynecology, Maastricht University Medical Centre, The Netherlands.
BMC Womens Health. 2011 Jun 3;11:23. doi: 10.1186/1472-6874-11-23.
Pelvic organ prolapse (POP) is a condition affecting more than half of the women above age 40. The estimated lifetime risk of needing surgical management for POP is 11%. In patients undergoing POP surgery of the anterior vaginal wall, the re-operation rate is 30%. The recurrence risk is especially high in women with a levator ani defect. Such defect is present if there is a partially or completely detachment of the levator ani from the inferior ramus of the symphysis. Detecting levator ani defects is relevant for counseling, and probably also for treatment. Levator ani defects can be imaged with MRI and also with Translabial 3D ultrasonography of the pelvic floor. The primary aim of this study is to assess the diagnostic accuracy of translabial 3D ultrasonography for diagnosing levator defects in women with POP with Magnetic Resonance Imaging as the reference standard. Secondary goals of this study include quantification of the inter-observer agreement about levator ani defects and determining the association between levator defects and recurrent POP after anterior repair. In addition, the cost-effectiveness of adding translabial ultrasonography to the diagnostic work-up in patients with POP will be estimated in a decision analytic model.
METHODS/DESIGN: A multicentre cohort study will be performed in nine Dutch hospitals. 140 consecutive women with a POPQ stage 2 or more anterior vaginal wall prolapse, who are indicated for anterior colporapphy will be included. Patients undergoing additional prolapse procedures will also be included. Prior to surgery, patients will undergo MR imaging and translabial 3D ultrasound examination of the pelvic floor. Patients will be asked to complete validated disease specific quality of life questionnaires before surgery and at six and twelve months after surgery. Pelvic examination will be performed at the same time points. Assuming a sensitivity and specificity of 90% of 3D ultrasound for diagnosing levator defects in a population of 120 women with POP, with a prior probability of levator ani defects of 40%, we will be able to estimate predictive values with good accuracy (i.e. confidence limits of at most 10% below or above the point estimates of positive and negative predictive values).Anticipating 3% unclassifiable diagnostic images because of technical reasons, and a further safety margin of 10% we plan to recruit 140 patients.
Nederlands trial register NTR2220.
盆腔器官脱垂（POP）是一种影响 40 岁以上女性半数以上的疾病。POP 患者需要手术治疗的终身风险估计为 11%。在前阴道壁 POP 手术中，再次手术率为 30%。在存在会阴体缺陷的女性中，复发风险尤其高。如果会阴体部分或完全与耻骨联合下支分离，则存在会阴体缺陷。检测会阴体缺陷与咨询相关，可能也与治疗相关。MRI 和经阴道 3D 超声盆底成像可用于检测会阴体缺陷。本研究的主要目的是评估经阴道 3D 超声对以磁共振成像（MRI）为参考标准的 POP 患者会阴体缺陷的诊断准确性。本研究的次要目标包括评估会阴体缺陷的观察者间一致性，并确定会阴体缺陷与前修补术后复发性 POP 之间的关联。此外，将在决策分析模型中估算在 POP 患者的诊断工作中添加经阴道超声的成本效益。
方法/设计：这是一项在荷兰 9 家医院进行的多中心队列研究。将纳入 140 例 POPQ 分期为 2 度或更高级别的前阴道壁脱垂且需要行前阴道修补术的连续患者。同时也将纳入行其他脱垂手术的患者。在手术前，患者将接受 MRI 和经阴道 3D 超声盆底检查。患者将在手术前和手术后 6 个月和 12 个月时被要求完成经认可的特定疾病生活质量问卷。同时还将在相同的时间点进行盆腔检查。假设在 120 例 POP 患者中，3D 超声对诊断会阴体缺陷的敏感度和特异度为 90%，会阴体缺陷的先验概率为 40%，我们将能够以较高的准确性（即阳性和阴性预测值的置信区间最多低于或高于点估计值 10%）估计预测值。预计由于技术原因有 3%的不可分类的诊断图像，并且再留出 10%的安全边际，我们计划招募 140 例患者。
荷兰试验注册 NTR2220。
