NCT05862155

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 5, 2023

Last Update Submit

May 16, 2023

Conditions

Keywords

adhesionvesicouterinebladderuterusreal-time dynamictransvaginal sonographysliding signultrasound

Outcome Measures

Primary Outcomes (1)

  • Transvaginal sonographic sliding sign

    Real-time dynamic transvaginal sonographic sliding sign (positive or negative sign)

    Preoperative

Secondary Outcomes (1)

  • Adhesion score

    Intraoperative recording of laparoscopic footage with postoperative assessment of the adhesion score based on this video within 2 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Insufficient quality of the ultrasound
  • Unclear laparoscopic videoclip to determine the presence of adhesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 29575202BACKGROUND
  • Hudelist 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.

    PMID: 19202143BACKGROUND
  • Tulandi T, Lyell DJ. Classification of intra-abdominal adhesions after cesarean delivery. Gynecol Surg. 2013;10(1):25-9.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

GynatresiaTissue Adhesions

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Judith Huirne, Prof. Dr.

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. J.A.F. Huirne

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 17, 2023

Study Start

January 27, 2020

Primary Completion

January 19, 2022

Study Completion

February 13, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations