By 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.
ID
Bron
Verkorte titel
Aandoening
The lifetime risk for women to be operated because of pelvic organ prolapse (POP) is 11%. In the Netherlands yearly 13.000 patients undergo surgical correction because of pelvic organ prolapse. These operations are known to have a high re-operation rate (30%) because of primary failure and secondary recurrence.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The diagnostic test characteristics of 3D ultrasonography in diagnosing levator defects compared to MRI.
Achtergrond van het onderzoek
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 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.
Doel van het onderzoek
By 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.
Onderzoeksopzet
1. Preoperatively;
2. Operation and hospital stay;
3. Follow-up at 6 weeks, 6 months and 12 months.
Onderzoeksproduct en/of interventie
1. Questionnaires;
2. Physical examination;
3. Translabial 3D ultrasonography;
4. MR Imaging.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2103 |
| NTR-old | NTR2220 |
| Ander register | Maastricht UMC : MEC 08-2-093 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |