Anovaginal Distance, Interobserver Agreement

Completed

• Conditions: Pelvic Floor Disorders
• Interventions: Other: anovaginal distance variation

• Registration Number: NCT02943018
• Lead Sponsor: Ostergotland County Council, Sweden

Brief Summary

Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound

Detailed Description

Aims: This study describes perineal ultrasound measurement of the AVD in regard to ease of learning and interobserver agreement, in order to establish if the method is reliable to use in further research about objective postpartum description of perineal tears.

Methods: To educate the examiners, the method was shown and described by an experienced examiner. The examiners then measured the anovaginal distance in one woman repeatedly with until similar results (+/- 5 mm ) were achieved. The woman was in the lithotomy position and a vaginal ultrasound probe was used. The AVD in another 40 women was then measured and documented by two examiners, right after the other, who were blinded to the other´s results. The distance was measured between the mucosal margin of the internal anal sphincter and the vaginal probe. Interobserver agreement was calculated using Kappa-score.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-21
• Last Update Submitted: 2016-10-21
• Study First Posted: 2016-10-24
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Examiners; the gynecologists authoring the study

Patients:

• any women visiting the gynaecological outpatient clinic of Linköping University Hospital where a vaginal ultrasound examination was performed

Exclusion Criteria

Examiners: n/a

Patients:

• inability to understand spoken or written Swedish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anovaginal distance variation	anovaginal distance variation	3 measurements

Primary Outcome Measures

Name	Time	Method
interobserver variation in measurements of the anovaginal distance with perineal ultrasound	immediate	3 measurements per investigator and patient, comparing variation, using kappa value

Secondary Outcome Measures

Name	Time	Method
Ease of learning the technique of perineal ultrasound to measure the anovaginal distance	immediate	how many measurements did the investigator learning the procedure need to perform produce a measurement that was within 5 mm of the measurements of the teacher