Clinical trial NCT06787352: Ultrasound Features of Endometriosis of the Uterosacral Ligaments
Official title: Ultrasound Features of Endometriosis of the Uterosacral Ligaments
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometriosis
Keywords: endometriosis
gynaecology
surgery
uterus sacral ligaments
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidates for surgery for clinically and/or ultrasound-diagnosed endometriosis, referred to the presurgical outpatient clinic of the participating centres

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women with a clinical and/or ultrasound diagnosis of endometriosis who are candidates for surgery;
* Age between 18 and 50 years;
* Signature of informed consent to the study

Exclusion Criteria:

* Post-menopausal women (spontaneous or iatrogenic);
* Virgo patients;
* Hysterectomised patients;
* Pregnant patients;
* Patients undergoing pelvic/vaginal radiotherapy;
* Previous LUS surgery;
* Clinical diagnosis of pelvic organ prolapse;
* Preoperative ultrasound more than 60 days prior to surgery;
* Failure at surgery and any subsequent histopathological examination to find pelvic endometriosis

Primary outcomes:
measure: Diagnostic ability of anteroposterior LUS thickness
timeFrame: During the first visit after enrollment
Secondary outcomes:
measure: Learning curve of average experienced operators (Doctors in Specialised Training, MFS) in acquiring the optimal measurement of anteroposterior LUS thickness
timeFrame: During the first visit after enrollment
measure: Evaluation of ultrasound parameters and differences between the two study groups
timeFrame: During the first visit after enrollment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Diego Raimondo, MD
role: PRINCIPAL_INVESTIGATOR
References: