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Translabial 3D ultrasonography for diagnosing levator defects.


- candidate number7770
- NTR NumberNTR2220
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2010
- Secondary IDsMEC 08-2-093 Maastricht UMC
- Public TitleTranslabial 3D ultrasonography for diagnosing levator defects.
- Scientific TitleTranslabial 3D ultrasonography for diagnosing levator defects.
- ACRONYMTRUDIL
- hypothesisBy validating translabial 3D ultrasonography we will have a new method for selecting patients at risk for recurrence after primary conventional pelvic organ prolapse surgery by diagnosing levator defects in the pelvic floor.
- Healt Condition(s) or Problem(s) studiedPelvic organ prolaps, Surgical treatment, Levatordefects, Ultrasonography
- Inclusion criteriaWomen with at least POPQ stage II descent of the anterior compartment who are scheduled for colporraphia anterior alone or in combination with other pelvic organ prolapse surgery.
- Exclusion criteria1. Previous POP surgery;
2. The intention to use mesh-materials;
3. Claustrophobia;
4. Contra-indications for MR imaging (e.g. pace-maker, artificial valves, prosthesis).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2010
- planned closingdate1-sep-2012
- Target number of participants140
- Interventions1. Questionnaires;
2. Physical examination;
3. Translabial 3D ultrasonography;
4. MR Imaging.
- Primary outcomeThe diagnostic test characteristics of 3D ultrasonography in diagnosing levator defects compared to MRI.
- Secondary outcome1. Inter-observer agreement in diagnosing levator defects with 3D ultrasonography;
2. Determination whether levator defects are an independent risk factor for recurrence after POP surgery;
3. Potential cost-effectiveness of introducing 3D ultrasonography for diagnosing levator defects in the work-up of a patient with POP.
- Timepoints1. Preoperatively;
2. Operation and hospital stay;
3. Follow-up at 6 weeks, 6 months and 12 months.
- Trial web sitewww.obsgyn.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Kim Notten
- CONTACT for SCIENTIFIC QUERIESDrs. Mirjam Weemhoff
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryPrimary 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 pelvic organ [rolapse surgery. In addition the cost-effectiveness of introducing translabial ultrasonography in the work-up of a patient with pelvic organ prolapse will be estimated in a decision analytic model.
- Main changes (audit trail)
- RECORD16-feb-2010 - 5-mrt-2010


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