Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ, Netherlands
NCT Number: NCT05862155
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.
Looking for future studies?
Notify Me18 year and older
Female
Observational
Amsterdam, North Holland, 1105 AZ, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Preoperative
Real-time dynamic transvaginal sonographic sliding sign (positive or negative sign)
Time frame: Intraoperative recording of laparoscopic footage with postoperative assessment of the adhesion score based on this video within 2 years
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'.
Amsterdam UMC, location VUmc
Other
Prediction of Vesicouterine Adhesions by the Real-time Dynamic Transvaginal Sonographic Sliding Sign Technique: a Validation Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04088838
Adhesions Abdominal, Adhesions Pelvic
Boxmeer, Gelderland, Netherlands
View Trial DetailsNCT04302545
Adhesions Pelvic, Bladder Injury
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07523698
Adhesion; Bladder, Adhesions Uterus
Adana, Yuregir, Turkey (Türkiye)
View Trial DetailsNCT04638855
Cicatrix, Female Urogenital Diseases
Seoul, South Korea
View Trial Details