Adhesions PelvicNCT05862155
Prediction of Vesicouterine Adhesions by Transvaginal Sonographic Sliding Sign Technique: a Validation Study
An observational study of Adhesions Pelvic and Adhesion; Uterus, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The aim of this study is to evaluate the predictive value of the real-time dynamic TVS sliding sign for vesicouterine pouch adhesions in women and to test the inter- and intraobserver agreement of this new technique. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adhesions Pelvic, Adhesion; Uterus, Adhesion; Bladder
- How many people
- 132 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jan 2020to 13 Feb 2023
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing laparoscopic gynecological surgery at the Amsterdam UMC, location AMC who signed informed consent for the Status Studies, Niche Cohort or QUESTA study.
Who may be able to join
- Women > 18 years old
- Laparoscopic abdominopelvic surgery with available video footage in Clinical Assistent
- Recorded real-time dynamic transvaginal ultrasound with the sliding sign technique
- Signed informed consent
Who cannot join
- Insufficient quality of the ultrasound
- Unclear laparoscopic videoclip to determine the presence of adhesions
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
About this study
Official title: Prediction of Vesicouterine Adhesions by the Real-time Dynamic Transvaginal Sonographic Sliding Sign Technique: a Validation Study
The aim of this study is to evaluate the predictive value of the real-time dynamic TVS sliding sign for vesicouterine pouch adhesions in women and to test the inter- and intraobserver agreement of this new technique.
Read the detailed description
The investigators will conduct a prospective observational double-blind cohort study of patients who will have laparoscopic abdominopelvic surgery between January 2020 and December 2022 in the Amsterdam UMC. All women will be examined by TVE ultrasounds prior to surgery. The investigators will evaluate the predictive value of the real-time dynamic TVS sliding sign for vesicouterine pouch adhesions in women and test the inter- and intraobserver agreement of this technique.
All real-time dynamic transvaginal ultrasounds will be performed as followed: By mild pressure with the vaginal probe in the anterior vagina and palpation on the fundus with the free hand, the uterus will be pushed away from the bladder. The sliding-sign will be considered to be positive when the anterior wall glided freely in relation tot the bladder, one against the other. The sliding-sign was negative when the bladder is fixated tot the uterus for more than 1 cm from the vesico-vaginal fold. Or when the distance between the vesico-vaginal fold and the vesico-uterine fold is > 1 cm.
Two experienced gynaecologists and one resident in gynecology and obstetrics will evaluate the ultrasounds on the presence of the sliding sign independent from each other and without any knowledge of the individual patient and laparoscopic footage. All ultrasounds will be coded, so the assessors are blinded for the patients demographics and surgical history in order to interpret the sliding sign objectively.
The recorded laparoscopic videoclips will be evaluated by one of the researchers without any knowledge of the individual patient, surgical history and ultrasounds. Therefore the laparoscopic footage will be coded. To prevent bias the assessor will be blinded to the results of the ultrasound sliding sign assessments. Adhesions between uterus and bladder, abdominal fascia and omentum are scored according the classification of Tulandi. An adhesion score of 0 will be classified as no adhesions and an adhesion score of >16 as a 'frozen bladder'.
The obtained data will be analyzed to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the sliding sign to predict the presence of absence of adhesions between the bladder and uterus. Fisher's exact test will be used to calculate the p-value for prediction of adhesions using the sliding sign technique. A P < 0.05 will be considered statistically significant. Interobserver variability will be assesed between two experienced gynecologists and between one experienced gynecologist and the resident. To assess the intraobserver variability one of the experienced gynecologists will reevaluated the same ultrasounds 2 months after the first ultrasound evaluation.
The investigators will try to obtain 100 inclusions based on previous studies who studied the role of the abdominal sonographic sliding sign in predicting intra-abdominal adhesions in pregnant women undergoing repeat cesarean section. All women have signed an informed consent.
- Conditions
- Adhesions Pelvic, Adhesion; Uterus, Adhesion; Bladder
- Keywords
- adhesion, vesicouterine, bladder, uterus, real-time dynamic, transvaginal sonography, sliding sign, ultrasound
- Medical subject headings
- Gynatresia, Tissue Adhesions
What is being measured
The primary outcome is the main question the study is designed to answer.
Transvaginal sonographic sliding sign
Real-time dynamic transvaginal sonographic sliding sign (positive or negative sign)
Measured: Preoperative
Secondary outcomes (1)
Adhesion score
Adjusted classification of adhesions between uterus and bladder, abdominal fascia and omentum during laparoscopy. Total adhesion score of 0 = no adhesions. Total adhesion score of >16 = 'Frozen Bladder'.
Measured: Intraoperative recording of laparoscopic footage with postoperative assessment of the adhesion score based on this video within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start27 Jan 2020
- Primary completion19 Jan 2022
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adhesions PelvicStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.A.F. Huirne, Amsterdam UMC, location VUmc
- Investigators
- Judith Huirne, Prof. Dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862155
- Sponsor's protocol ID
- Sliding Bladder
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baron J, Tirosh D, Mastrolia SA, Ben-Haroush Y, Schwartz S, Kerner Y, Hershkovitz R. Sliding sign in third-trimester sonographic evaluation of intra-abdominal adhesions in women undergoing repeat Cesarean section: a novel technique. Ultrasound Obstet Gynecol. 2018 Nov;52(5):662-665. doi: 10.1002/uog.19057.
PubMed 29575202Hudelist G, Oberwinkler KH, Singer CF, Tuttlies F, Rauter G, Ritter O, Keckstein J. Combination of transvaginal sonography and clinical examination for preoperative diagnosis of pelvic endometriosis. Hum Reprod. 2009 May;24(5):1018-24. doi: 10.1093/humrep/dep013. Epub 2009 Feb 6.
PubMed 19202143Tulandi T, Lyell DJ. Classification of intra-abdominal adhesions after cesarean delivery. Gynecol Surg. 2013;10(1):25-9.
Min N, van Keizerswaard J, Visser RH, Burger NB, Rake JWT, Aarts JWM, Van den Bosch T, Leonardi M, Huirne JAF, de Leeuw RA. Prediction of vesicouterine adhesions by transvaginal sonographic sliding sign technique: validation study. Ultrasound Obstet Gynecol. 2025 Jan;65(1):114-121. doi: 10.1002/uog.29128. Epub 2024 Nov 25.
PubMed 39587459
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Vesicouterine Adhesions by the Real-time Dynamic Transvaginal Sonographic Sliding Sign Technique: a Validation Study
- ClinicalTrials.gov ID
- NCT05862155
- Acronym / sponsor ID
- Sliding Bladder
- Conditions
- Adhesions Pelvic, Adhesion; Uterus, Adhesion; Bladder
- Keywords
- adhesion, vesicouterine, bladder, uterus, real-time dynamic, transvaginal sonography, sliding sign, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 17 May 2023 (actual)
- 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.
The aim of this study is to evaluate the predictive value of the real-time dynamic TVS sliding sign for vesicouterine pouch adhesions in women and to test the inter- and intraobserver agreement of this new technique.
Detailed description
The investigators will conduct a prospective observational double-blind cohort study of patients who will have laparoscopic abdominopelvic surgery between January 2020 and December 2022 in the Amsterdam UMC. All women will be examined by TVE ultrasounds prior to surgery. The investigators will evaluate the predictive value of the real-time dynamic TVS sliding sign for vesicouterine pouch adhesions in women and test the inter- and intraobserver agreement of this technique.
All real-time dynamic transvaginal ultrasounds will be performed as followed: By mild pressure with the vaginal probe in the anterior vagina and palpation on the fundus with the free hand, the uterus will be pushed away from the bladder. The sliding-sign will be considered to be positive when the anterior wall glided freely in relation tot the bladder, one against the other. The sliding-sign was negative when the bladder is fixated tot the uterus for more than 1 cm from the vesico-vaginal fold. Or when the distance between the vesico-vaginal fold and the vesico-uterine fold is > 1 cm.
Two experienced gynaecologists and one resident in gynecology and obstetrics will evaluate the ultrasounds on the presence of the sliding sign independent from each other and without any knowledge of the individual patient and laparoscopic footage. All ultrasounds will be coded, so the assessors are blinded for the patients demographics and surgical history in order to interpret the sliding sign objectively.
The recorded laparoscopic videoclips will be evaluated by one of the researchers without any knowledge of the individual patient, surgical history and ultrasounds. Therefore the laparoscopic footage will be coded. To prevent bias the assessor will be blinded to the results of the ultrasound sliding sign assessments. Adhesions between uterus and bladder, abdominal fascia and omentum are scored according the classification of Tulandi. An adhesion score of 0 will be classified as no adhesions and an adhesion score of >16 as a 'frozen bladder'.
The obtained data will be analyzed to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the sliding sign to predict the presence of absence of adhesions between the bladder and uterus. Fisher's exact test will be used to calculate the p-value for prediction of adhesions using the sliding sign technique. A P < 0.05 will be considered statistically significant. Interobserver variability will be assesed between two experienced gynecologists and between one experienced gynecologist and the resident. To assess the intraobserver variability one of the experienced gynecologists will reevaluated the same ultrasounds 2 months after the first ultrasound evaluation.
The investigators will try to obtain 100 inclusions based on previous studies who studied the role of the abdominal sonographic sliding sign in predicting intra-abdominal adhesions in pregnant women undergoing repeat cesarean section. All women have signed an informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing laparoscopic gynecological surgery at the Amsterdam UMC, location AMC who signed informed consent for the Status Studies, Niche Cohort or QUESTA study.
Key inclusion criteria (4 listed)
- Women > 18 years old
- Laparoscopic abdominopelvic surgery with available video footage in Clinical Assistent
- Recorded real-time dynamic transvaginal ultrasound with the sliding sign technique
- Signed informed consent
Key exclusion criteria (2 listed)
- Insufficient quality of the ultrasound
- Unclear laparoscopic videoclip to determine the presence of adhesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transvaginal sonographic sliding sign
Time frame: Preoperative
Real-time dynamic transvaginal sonographic sliding sign (positive or negative sign)
1 secondary outcome
Adhesion score
Time frame: Intraoperative recording of laparoscopic footage with postoperative assessment of the adhesion score based on this video within 2 years
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 17 May 2023.
- Background: PubMed 29575202Baron J, Tirosh D, Mastrolia SA, Ben-Haroush Y, Schwartz S, Kerner Y, Hershkovitz R. Sliding sign in third-trimester sonographic evaluation of intra-abdominal adhesions in women undergoing repeat Cesarean section: a novel technique. Ultrasound Obstet Gynecol. 2018 Nov;52(5):662-665. doi: 10.1002/uog.19057.
- Background: PubMed 19202143Hudelist G, Oberwinkler KH, Singer CF, Tuttlies F, Rauter G, Ritter O, Keckstein J. Combination of transvaginal sonography and clinical examination for preoperative diagnosis of pelvic endometriosis. Hum Reprod. 2009 May;24(5):1018-24. doi: 10.1093/humrep/dep013. Epub 2009 Feb 6.
- BackgroundTulandi T, Lyell DJ. Classification of intra-abdominal adhesions after cesarean delivery. Gynecol Surg. 2013;10(1):25-9.
- Derived from this study: PubMed 39587459Min N, van Keizerswaard J, Visser RH, Burger NB, Rake JWT, Aarts JWM, Van den Bosch T, Leonardi M, Huirne JAF, de Leeuw RA. Prediction of vesicouterine adhesions by transvaginal sonographic sliding sign technique: validation study. Ultrasound Obstet Gynecol. 2025 Jan;65(1):114-121. doi: 10.1002/uog.29128. Epub 2024 Nov 25.
- Individual participant dataSharing planned: Undecided
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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.
Judith Huirne, Prof. Dr. principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesions Pelvic and Adhesion; Uterus, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 4 inclusion and 2 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Transvaginal sonographic sliding sign (time frame: Preoperative). 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 NCT05862155, which also lists 4 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 17 May 2023.