Pelvic Floor DisordersNCT02943018
Anovaginal Distance, Interobserver Agreement
An observational study of Pelvic Floor Disorders, run by Ostergotland County Council, Sweden.
Trial summary
Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound Read more about this study
- Who is it for?
- Ages 20 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- anovaginal distance variation
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The examiners whose measurements were compared for interobserver varialility were gynecologists working inte the department. The study population to perform measurements on was recruited from women visiting the gynaecological outpatient clinic of Linköping University Hospital.
Who may be able to join
- 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
Who cannot join
- Examiners: n/a
- Patients:
- inability to understand spoken or written Swedish
About this study
Official title: Interobserver Agreement in Perineal Ultrasound of the Anovaginal Distance- a Methodology-study
Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- anovaginal distance variation
- Keywords
- ultrasound anovaginal distance, observer variation
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anovaginal distance variationOther
Kappa calculation
| Study group | Role | What they receive |
|---|---|---|
| anovaginal distance variation | 3 measurements Receives: Other: anovaginal distance variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
interobserver variation in measurements of the anovaginal distance with perineal ultrasound
3 measurements per investigator and patient, comparing variation, using kappa value
Measured: immediate
Secondary outcomes (1)
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
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Uustal, Ostergotland County Council, Sweden
- Investigators
- Marie I Blomberg, MD PhD, Principal investigator, head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943018
- Sponsor's protocol ID
- OstergotlandCCAVD
- Status last verified
- Oct 2016
- First submitted
- 18 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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. doi: 10.1097/01.AOG.0000165273.68486.95.
PubMed 15994610Starck 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. doi: 10.1002/uog.1818.
PubMed 15685668Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. doi: 10.1111/j.1471-0528.2006.00799.x.
PubMed 16411998Peschers 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. doi: 10.1111/j.1471-0528.1997.tb12056.x.
PubMed 9307524Poen 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. doi: 10.1046/j.1365-2168.1998.00616.x.
PubMed 9529493Stewart LK, Wilson SR. Transvaginal sonography of the anal sphincter: reliable, or not? AJR Am J Roentgenol. 1999 Jul;173(1):179-85. doi: 10.2214/ajr.173.1.10397123.
PubMed 10397123Frudinger 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. doi: 10.2214/ajr.168.6.9168703.
PubMed 9168703Timor-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. doi: 10.1002/uog.1827.
PubMed 15660445Yang 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.
PubMed 19306473Olsen 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.
PubMed 21337656Valsky 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. doi: 10.1002/uog.3923.
PubMed 17219371Shobeiri 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.
PubMed 22402641Falkert A, Willmann A, Endress E, Meint P, Seelbach-Gobel 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.
PubMed 22745047Santoro 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.
PubMed 26382090Sultan 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. doi: 10.1007/BF02257800.
PubMed 7995162
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interobserver Agreement in Perineal Ultrasound of the Anovaginal Distance- a Methodology-study
- ClinicalTrials.gov ID
- NCT02943018
- Acronym / sponsor ID
- OstergotlandCCAVD
- Conditions
- Pelvic Floor Disorders
- Keywords
- ultrasound anovaginal distance, observer variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anovaginal distance variation | – | Other: anovaginal distance variation3 measurements |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The examiners whose measurements were compared for interobserver varialility were gynecologists working inte the department. The study population to perform measurements on was recruited from women visiting the gynaecological outpatient clinic of Linköping University Hospital.
Key inclusion criteria (3 listed)
- Examiners; the gynecologists authoring the study
- any women visiting the gynaecological outpatient clinic of Linköping University Hospital where a vaginal ultrasound examination was performed
Key exclusion criteria (3 listed)
- Examiners: n/a
- inability to understand spoken or written Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anovaginal distance variationKappa calculation | Other | anovaginal distance variation |
Primary outcome
interobserver variation in measurements of the anovaginal distance with perineal ultrasound
Time frame: immediate
3 measurements per investigator and patient, comparing variation, using kappa value
1 secondary outcome
Ease of learning the technique of perineal ultrasound to measure the anovaginal distance
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Background: PubMed 15994610Faltin 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. doi: 10.1097/01.AOG.0000165273.68486.95.
- Background: PubMed 15685668Starck 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. doi: 10.1002/uog.1818.
- Background: PubMed 16411998Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. doi: 10.1111/j.1471-0528.2006.00799.x.
- Background: PubMed 9307524Peschers 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. doi: 10.1111/j.1471-0528.1997.tb12056.x.
- Background: PubMed 9529493Poen 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. doi: 10.1046/j.1365-2168.1998.00616.x.
- Background: PubMed 10397123Stewart LK, Wilson SR. Transvaginal sonography of the anal sphincter: reliable, or not? AJR Am J Roentgenol. 1999 Jul;173(1):179-85. doi: 10.2214/ajr.173.1.10397123.
- Background: PubMed 9168703Frudinger 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. doi: 10.2214/ajr.168.6.9168703.
- Background: PubMed 15660445Timor-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. doi: 10.1002/uog.1827.
- Background: PubMed 19306473Yang 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.
- Background: PubMed 21337656Olsen 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.
- Background: PubMed 17219371Valsky 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. doi: 10.1002/uog.3923.
- Background: PubMed 22402641Shobeiri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie I Blomberg, MD PhD principal investigator
head of department
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Ostergotland County Council, Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interobserver variation in measurements of the anovaginal distance with perineal ultrasound (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943018, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.