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TRUDIL study

 

Translabial 3D-Ultrasonography for Diagnosing Levatordefects

 

Go to the TRUDIL website.

 

Objective
Primary aim of the study is estimating the diagnostic accuracy of translabial 3D ultrasonography of the pelvic floor as compared to MR imaging, the reference standard, for diagnosing levator defects in women with pelvic organ prolapse. Our secondary aim is estimating the level of agreement between observers. We will examine whether levator defects are a risk factor for recurrence after prolapse surgery. In addition the cost-effectiveness of introducing translabial ultrasonography in the work-up of a patient with prolapse will be estimated in a simple decision analytic model.

 

Study design
Multicentre prospective observational cohort study

Study population
Women with at least POP-Q stage II pelvic organ prolapse of the anterior compartment who are scheduled to undergo a conventional colporapphia anterior, without the use of mesh-materials

Intervention
Questionnaires, physical examination, 3D ultrasonography, MR imaging

 

Outcome measures
1. The diagnostic test characteristics of 3D ultrasonography in diagnosing levator defects compared to MRI: sensitivity, specificity, positive predictive value, negative predictive value.

2. Inter-observer agreement in diagnosing levator defects with 3D ultrasonography.

3. Determination whether levator defects are an independent risk factor for recurrence after POP surgery.

4. Potential cost-effectiveness of introducing 3D ultrasonography for diagnosing levator defects in the work-up of a patient with prolapse.

Power/data analysis
Assuming a sensitivity and specificity of 90% in a population of women with pelvic organ prolapse with a prior probability of levator defects of 40% and a sample size of 120, we will be able to estimate predictive values with some 10% below or above the point estimate of PV+ and PV-.


Economic evaluation
Potential cost-effectiveness of translabial 3D ultrasound in the diagnostic work-up of a patient with prolapse will be determined from a hospital perspective from study entry up to 6 and 12 months follow-up. A simple decision analytical model will be constructed in which expected hospital costs and effectiveness related to the introduction of translabial 3D ultrasound for identifying patients at risk for recurrence and subsequent adjustment of the type of surgery (use of mesh-material in primary surgery) will be compared with other diagnostic strategies.


Time schedule
Start inclusion March 2010. Inclusion period 12 months. Follow up 24 months.

Projectleader

Mirjam Weemhoff, MD, Dept. Of Gynecology, Maastricht UMC, The Netherlands

 

Methodology

Luc Smits, PhD, Dept. Of Epidemiology, Maastricht UMC, The Netherlands

Patrick Bossuyt, PhD, Dept. of Epidemiology, AMC Amsterdam, The Netherlands

 

Subsidy
ZonMw

 

Contact

Kim Notten, MD

Maastricht University Medical Centre

Department of Obstetrics and Gynaecology

P.O. Box 5800, 6202 AZ Maastricht,

T: +31 (0) 43-3876764

email: trudil@studies-obsgyn.nl