NCT05540821

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

Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis: a Prospective Diagnostic Test

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 156 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Deep Endometriosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hysterosalpingo-contrast sonography and sonoPODography	Before operation, phloroglucinol 40mg of antispasmolysis was injected intramuscular, and then cervical dilation was performed according to aseptic operation requirements. A 12G double-lumen catheter was inserted into the uterine cavity, and 1.5-1.8ml of normal saline was injected into the sacculus. Transvaginal 2/3/4D hysterosalpingo-contrast sonography: One operator extracted 2ml of Sonovue and injected 18ml of normal saline through a dual-lumen catheter, and the other operator started the four-dimensional ultrasound mode to collect dynamic volume data. sonoPODography: Sterile saline was injected into the intrauterine cavity, with an upper limit of 20ml. The normal saline flowed from the intrauterine cavity into the pelvic cavity through the bilateral fallopian tubes, forming a good acoustic window. Pelvic observation was then performed.

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-09-15
• Last updated: 2022-09-15

Locations

1 site across 1 country: China