Nutritional Intervention for Endometriosis
NCT05175248
Endometriosis, Female Urogenital Diseases
Washington D.C., District of Columbia, United States
View Trial DetailsNCT Number: NCT06787352
Ultrasound features most indicative of endometriosis of the uterosacral ligaments, which connect the cervix to the sacrum and are part of the uterus support structures, and verify the actual presence of endometriosis of these ligaments during surgery
This study is active but is not currently recruiting participants.
Notify Me18 year–50 year
Female
Observational
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
It is estimated that 1 in 10 women of childbearing age is affected by endometriosis. Objective examination alone is not sufficient to frame the pathology as the anatomic-clinical correspondence is relatively low: symptoms are not lesion specific and there may be asymptomatic women with pictures of severe endometriosis. Accurate diagnosis of all endometriosis by transvaginal ultrasound at the preoperative stage is therefore essential to discriminate patients who need surgery from those who can benefit from medical therapy alone, but also to be able to select a surgeon with adequate experience for this type of surgery. In recent years, moreover, it has been highlighted that ureteral endometriosis is associated with ipsilateral LUS injury. Ureteral damage has a nuanced symptomatology and cases in which the patient manifests signs and symptoms suggestive of renal resentment are rare (flank pain, renal colic, hypertension). Ureteral involvement can therefore lead to a silent loss of renal function, which in some cases requires nephrectomy. Several studies have already shown that there is a correlation between ureteral endometriosis and uterosacral ligaments (LUS) endometriosis, and that the likelihood of ureteral involvement increases with increasing nodule size. In light of this evidence and in order to improve the diagnostic power of the ultrasound method, it is therefore important to find the best combination of ultrasound parameters to predict endometriosis in LUS with sufficient accuracy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During the first visit after enrollment
Comparison of the average thickness in millimetres of LUS with endometriosis and healthy LUS. The thickness cut-off of the LUS with highest diagnostic accuracy will be calculated by Receiver operating characteristic (ROC) curves
Time frame: During the first visit after enrollment
The agreement between the measurements of the two experienced operators and between those of the average experienced operators will be studied by calculating the measurement error using the Bland-Altman plot. The cumulative sum test for the learning curve (LC-CUSUM) will then be used to evaluate the learning curve
Time frame: During the first visit after enrollment
Comparison of the prevalence of the above-mentioned ultrasound features in the two groups (ratio of the number of sick LUSs with one of the features to the total number of sick LUSs - ratio of the number of healthy LUSs with one of the features to the total number of healthy LUSs), analysing them both individually and in combination until the combination with the best sensitivity and specificity is identified
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
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