Protocol for Translabial 3D-Ultrasonography for diagnosing levator defects (TRUDIL): a multicentre cohort study for estimating the diagnostic accuracy of translabial 3D-ultrasonography of the pelvic floor as compared to MR imaging

Contains fulltext : 96237.pdf (publisher's version ) (Open Access)BACKGROUND: 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. TRIAL REGISTRATION: Nederlands trial register NTR2220

The Extended Reconstruction of the Pubocervical Layer Appears Superior to the Simple Plication of the Bladder Adventitia concerning Anterior Colporrhaphy: A Description of Two Techniques in an Observational Retrospective Analysis

&lt;i&gt;Aims:&lt;/i&gt; This observational retrospective analysis was done to compare the plication of the bladder adventitia with the reconstruction of the pubocervical layer concerning the reoperation rate for recurrent cystocele. &lt;i&gt;Methods:&lt;/i&gt; Sixty-five patients underwent an anterior vaginal wall repair using traditional techniques. In 11 patients, the prolapse was corrected by simply plicating the adventitia of the posterior bladder wall (group A), and in 54 patients the pubocervical layer was rebuilt using structures of the endopelvic fascia following far lateral dissection of the vaginal flaps (group B). The anatomical state was documented via the Pelvic Organ Prolapse Quantification system. &lt;i&gt;Results:&lt;/i&gt; The overall reoperation rate of cystoceles was 6% after a mean follow-up of 2 years. Three out of 11 patients of group A and 1/54 patients of group B underwent repeat surgery (p &lt; 0.005). No complications were observed in group A (0/11). In contrast, seven complications were related to the reconstruction of the pubocervical layer (7/54, p &gt; 0.05). Two patients presented with ureteral obstruction, one of them requiring temporary nephrostomy. &lt;i&gt;Conclusion:&lt;/i&gt; Compared with the plication of the bladder adventitia, the reoperation rate after reconstruction of the pubocervical layer is diminished. However, because of potential risks of ureteral injury, the procedure demands serious precaution.</jats:p

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