Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis

Shenzhen University

Status: Enrolling

Conditions: Deep Endometriosis

Treatments: Diagnostic Test: Hysterosalpingo-contrast sonography and sonoPODography

Study type: Observational

Funder types: Other

Identifiers

NCT05540821

20223357017

Details and patient eligibility

About

Endometriosis occurs in about 10-15% of women of childbearing age and is a major cause of infertility and dysmenorrhea. Deep endometriosis is the most serious manifestation of endometriosis, which often affects the quality of life of patients and requires surgical treatment. Detailed description of DE lesions before operation can contribute to treatment planning. However, the detection rate of DE by conventional ultrasound is low, highly dependent on the experience of the examiner and poor reproducibility. Hysterosalpingo-contrast sonography can be used to assess the patency of the fallopian tube but cannot visualize other pelvic structures. Saline-infusion sonoPODography can provide a good acoustic window for pelvic tissue visualization. Therefore, this study is the first to present double contrast-enhanced ultrasound (Hysterosalpingo-contrast sonography and sonoPODography) examination of the pelvic cavity, based on the #Enzian classification system, for preoperative evaluation of DE lesions. The results of laparoscopic surgery were taken as the gold standard to compare the diagnostic efficacy of double contrast-enhanced ultrasound and conventional transvaginal ultrasound in preoperative evaluation of pelvic DE lesions, improving the preoperative diagnosis, reduce the risk of surgery and reduce postoperative recurrence. To compare the diagnostic efficacy of different examination methods in different compartment of DE, and to explore the best examination method suitable for different parts of DE, providing theoretical basis for further early screening and personalized treatment of DE in the future.

Enrollment: 156 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients diagnosed with adenomyosis and/or chocolate cysts, suspected infertility with endometriosis, and proposed for laparoscopic surgery at our hospital.
2. Sexual life history.
3. Surgery was performed within 2 months of the examination.
4. Subjects volunteered to participate in the study and signed the informed consent form.

Exclusion criteria

1. colporrhagia.
2. Acute inflammation of reproductive system.
3. Allergic to ultrasound contrast agent (Sonovue).
4. Suspected malignant lesions of cervix or uterine cavity.

Trial design

156 participants in 2 patient groups

conventional transvaginal ultrasound group

double contrast-enhanced ultrasound group

Description:

perfromed hysterosalpingo-contrast sonography and sonoPODography examination

Treatment:

Diagnostic Test: Hysterosalpingo-contrast sonography and sonoPODography