Observational Study on the Use of Ultrasound to Recognize Superficial Endometriosis in a Specific Area of the Pelvis (the Uterosacral Ligaments)

Официальное название

Ultrasound Diagnosis of Superficial Endometriosis of LUS (Uterosacral Ligaments): Definition of a Laparoscopically Validated Ultrasound Cut-off.

Обзор

An observational, prospective, multicenter study conducted on patients of childbearing age undergoing laparoscopic surgery for early-stage benign or malignant gynecological disease. The study does not include changes to the standard care pathway.

Подробное описание

All patients enrolled in the study will undergo a level II gynecological ultrasound with a transvaginal approach.

The uterosacral ligaments will be identified ultrasound-wise at the level of the cervix in a transverse scan, in line with the scanning techniques described in the literature. The first measurement point will be located in the median area, at the level of the torus uterinus; the further two measurements will be taken at the level of the LUS (uterosacral ligaments) 1.5 cm to the right and 1.5 cm to the left with respect to the torus. For each patient, the three measurements will be recorded and the average of the values obtained will be calculated, considered as a parameter representative of the average thickness of the LUS (uterosacral ligaments). The acquired ultrasound images will be archived as per clinical practice.

Subsequently, patients will undergo laparoscopic surgery. During the procedure, the presence or absence of superficial endometriosis lesions of the LUS will be documented, as well as the presence of any other locations of deep and superficial disease, according to a predefined grid.

Finally, ultrasound and laparoscopic data will be compared to assess diagnostic concordance at the site of primary interest (LUS), with particular reference to ultrasound thickness as a possible indicator of the presence of laparoscopically confirmed superficial endometriosis.

Вмешательства

• Другое laparoscopic surgery for gynecological pathology
  Patients will be operated on by operators experienced in complex endometriotic surgery. Ultrasound and laparoscopic data will be compared regarding the site of interest for the study, the LUS. LUS thickness data will be recorded as a continuous variable in mm. The uterosacral ligaments (LUS) will be identified at the level of the cervix in a transverse scan, rotated by 45 °, according to the method described in the literature. At this site, LUS present as hyperechoic striae located posterior t

Первичные конечные точки

• measurement of of the thickness of the LUS (uterosacral ligaments) [Срок оценки: through study completion, an average of 1 year]
• diagnostic performance parameters [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• patients who need to undergo gynecological surgery with a laparoscopic approach for benign pathology (endometriosis, uterine fibroids, adenomyosis, chronic pelvic pain, benign ovarian cysts) or non-advanced malignant pathology (stage I endometrium and cervix, stage I and II ovary).
• patients who performed a level II gynecological ultrasound with an experienced operator in the preoperative pathway.
• technical possibility of performing a transvaginal ultrasound and the patient's willingness to undergo such an investigation.
• patients of childbearing age (18 - 50 years).
• Signing of informed consent.

Критерии исключения

• presence of endometriosis deeply infiltrating the posterior compartment. This may interfere with the interpretation of uterosacral ligament (LUS) thickness as a specific marker of superficial endometriosis
• technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
• incomplete ultrasound evaluation of the uterosacral ligaments for anatomical reasons or for the presence of endometriosis nodules from other sites with partial involvement of the LUS (uterosacral ligament).
• advanced malignant disease (>Stage I for endometrium and cervix, > Stage II for ovary)
• pelvic organ prolapse
• PID or other pelvic inflammatory diseases
• medical emergencies (ovarian torsion, hemoperitoneum)
• postmenopausal patients
• previous pelvic surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Италия · 4 центра

• Policlinico Universitario Federico II — Naples
• Policlinico Abano Terme — Abano Terme
• Presidio ospedaliero-universitario Santa Maria della Misericordia - Azienda Sanitaria Univ — Udine
• Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda

Идентификаторы

NCT: NCT07427849 · 818CET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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