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Learning curve and applicability of 3D/4D translabial ultrasound for diagnosing levator ani defects

Learning curve and applicability of 3D/4D translabial ultrasound for diagnosing levator ani defects - LCA study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36639
Enrollment
106
Registered
2011-01-12
Start date
2011-01-12
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

prolaps en incontinentie pelvic organ prolapse

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: women with symptoms of pelvic organ prolapse or incontinence.

Exclusion criteria

Exclusion criteria: younger than 18 people who are not able to understand the information

Design outcomes

Primary

MeasureTime frame
1. How many 3D ultrasoundscans of the pelvic floor does a gynecologist with experience in gynecological ultrasound need to perform to visualise all essential referencepoints to reach an inter observer agreement with a weighted kappa of 0.8 compared to an expert. 2. How many 3D ultrasoundscans of the pelvic floor does a student with no ultrasound experience need to perform to visualise all essential referencepoints to reach an inter observer agreement with a weighted kappa0.8. compared to an expert. 3. How many recorded ultrasoundscans does a gynecologist with experience in gynecological ultrasound need to read to learn to judge the integrity of the levator ani to reach an inter observer agreement with an ICC of 0.6. compared to an expert. 4. How many recorded ultrasoundscans does a student with ultrasound experience need to read to learn to judge the integrity of the levator ani to reach an inter observer agreement with an ICC of 0.6. compared to an expert.

Secondary

MeasureTime frame
5. What is the inter test agreement (weighted kappa) between a Voluson GE Kretz and Toshiba ultrasoundmachine in visualising the reference points essential in 3D ultrasound of the pelvic floor. 6. What is the inter test agreement (ICC) between a Voluson GE Kretz and Toshiba ultrasoundmachine in the judgement of the integrity of the levator ani.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)