Anovaginal Distance, Interobserver Agreement

Pelvic Floor Disorders Clinical Trial

Official title:

Interobserver Agreement in Perineal Ultrasound of the Anovaginal Distance- a Methodology-study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943018
• Other study ID #: OstergotlandCCAVD
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 21, 2016
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 100 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Other:
• anovaginal distance variation
Kappa calculation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ostergotland County Council, Sweden

References & Publications (23)

Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. — View Citation

Falkert A, Willmann A, Endress E, Meint P, Seelbach-Göbel B. Three-dimensional ultrasound of pelvic floor: is there a correlation with delivery mode and persisting pelvic floor disorders 18-24 months after first delivery? Ultrasound Obstet Gynecol. 2013 Feb;41(2):204-9. doi: 10.1002/uog.11214. — View Citation

Faltin DL, Boulvain M, Floris LA, Irion O. Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2005 Jul;106(1):6-13. — View Citation

Faltin DL, Boulvain M, Stan C, Epiney M, Weil A, Irion O. Intraobserver and interobserver agreement in the diagnosis of anal sphincter tears by postpartum endosonography. Ultrasound Obstet Gynecol. 2003 Apr;21(4):375-7. — View Citation

Frudinger A, Bartram CI, Kamm MA. Transvaginal versus anal endosonography for detecting damage to the anal sphincter. AJR Am J Roentgenol. 1997 Jun;168(6):1435-8. — View Citation

Hall RJ, Rogers RG, Saiz L, Qualls C. Translabial ultrasound assessment of the anal sphincter complex: normal measurements of the internal and external anal sphincters at the proximal, mid-, and distal levels. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Aug;18(8):881-8. Epub 2007 Jan 13. — View Citation

Larson KA, Yousuf A, Lewicky-Gaupp C, Fenner DE, DeLancey JO. Perineal body anatomy in living women: 3-dimensional analysis using thin-slice magnetic resonance imaging. Am J Obstet Gynecol. 2010 Nov;203(5):494.e15-21. doi: 10.1016/j.ajog.2010.06.008. — View Citation

Olsen IP, Wilsgaard T, Kiserud T. Transvaginal three-dimensional ultrasound: a method of studying anal anatomy and function. Ultrasound Obstet Gynecol. 2011 Mar;37(3):353-60. doi: 10.1002/uog.8873. — View Citation

Ozyurt S, Aksoy H, Gedikbasi A, Yildirim G, Aksoy U, Acmaz G, Ark C. Screening occult anal sphincter injuries in primigravid women after vaginal delivery with transperineal use of vaginal probe: a prospective, randomized controlled trial. Arch Gynecol Obstet. 2015 Oct;292(4):853-9. doi: 10.1007/s00404-015-3708-z. Epub 2015 Apr 10. — View Citation

Peschers UM, DeLancey JO, Schaer GN, Schuessler B. Exoanal ultrasound of the anal sphincter: normal anatomy and sphincter defects. Br J Obstet Gynaecol. 1997 Sep;104(9):999-1003. — View Citation

Poen AC, Felt-Bersma RJ, Cuesta MA, Meuwissen GM. Vaginal endosonography of the anal sphincter complex is important in the assessment of faecal incontinence and perianal sepsis. Br J Surg. 1998 Mar;85(3):359-63. — View Citation

Santoro GA, Shobeiri SA, Petros PP, Zapater P, Wieczorek AP. Perineal body anatomy seen by three-dimensional endovaginal ultrasound of asymptomatic nulliparae. Colorectal Dis. 2016 Apr;18(4):400-9. doi: 10.1111/codi.13119. — View Citation

Santoro GA, Wieczorek AP, Shobeiri SA, Mueller ER, Pilat J, Stankiewicz A, Battistella G. Interobserver and interdisciplinary reproducibility of 3D endovaginal ultrasound assessment of pelvic floor anatomy. Int Urogynecol J. 2011 Jan;22(1):53-9. doi: 10.1007/s00192-010-1233-y. Epub 2010 Aug 11. — View Citation

Shobeiri SA, White D, Quiroz LH, Nihira MA. Anterior and posterior compartment 3D endovaginal ultrasound anatomy based on direct histologic comparison. Int Urogynecol J. 2012 Aug;23(8):1047-53. doi: 10.1007/s00192-012-1721-3. Epub 2012 Mar 9. — View Citation

Starck M, Bohe M, Fortling B, Valentin L. Endosonography of the anal sphincter in women of different ages and parity. Ultrasound Obstet Gynecol. 2005 Feb;25(2):169-76. — View Citation

Stewart LK, Wilson SR. Transvaginal sonography of the anal sphincter: reliable, or not? AJR Am J Roentgenol. 1999 Jul;173(1):179-85. — View Citation

Sultan AH, Loder PB, Bartram CI, Kamm MA, Hudson CN. Vaginal endosonography. New approach to image the undisturbed anal sphincter. Dis Colon Rectum. 1994 Dec;37(12):1296-9. — View Citation

Timor-Tritsch IE, Monteagudo A, Smilen SW, Porges RF, Avizova E. Simple ultrasound evaluation of the anal sphincter in female patients using a transvaginal transducer. Ultrasound Obstet Gynecol. 2005 Feb;25(2):177-83. — View Citation

Uustal Fornell, E. The perineal body thickness - normal values and correlation to pelvic floor dysfunction. Abstract 344, IUGA 2005

Valsky DV, Messing B, Petkova R, Savchev S, Rosenak D, Hochner-Celnikier D, Yagel S. Postpartum evaluation of the anal sphincter by transperineal three-dimensional ultrasound in primiparous women after vaginal delivery and following surgical repair of third-degree tears by the overlapping technique. Ultrasound Obstet Gynecol. 2007 Feb;29(2):195-204. — View Citation

Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3. — View Citation

Yang SH, Huang WC, Yang SY, Yang E, Yang JM. Validation of new ultrasound parameters for quantifying pelvic floor muscle contraction. Ultrasound Obstet Gynecol. 2009 Apr;33(4):465-71. doi: 10.1002/uog.6338. — View Citation

Zetterström JP, Mellgren A, Madoff RD, Kim DG, Wong WD. Perineal body measurement improves evaluation of anterior sphincter lesions during endoanal ultrasonography. Dis Colon Rectum. 1998 Jun;41(6):705-13. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interobserver variation in measurements of the anovaginal distance with perineal ultrasound	3 measurements per investigator and patient, comparing variation, using kappa value	immediate	No
Secondary	Ease of learning the technique of perineal ultrasound to measure the anovaginal distance	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	immediate	No