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Translabial 3D ultrasonography for diagnosing levator defects.

Translabial 3D ultrasonography for diagnosing levator defects.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27743
Enrollment
140
Registered
2010-02-16
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

2. Physical examination
3. Translabial 3D ultrasonography
4. MR Imaging.

Sponsors

Maastricht university medical center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
The diagnostic test characteristics of 3D ultrasonography in diagnosing levator defects compared to MRI.

Secondary

MeasureTime frame
1. 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.

Contacts

Public ContactKim Notten

Postbus 5800

kim.notten@mumc.nl+31 (0)43 3876764

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)