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

Study Overview
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Brief Summary
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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.

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

Conditions
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Deep Endometriosis

Intervention / Treatment
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* Diagnostic Test: Hysterosalpingo-contrast sonography and sonoPODography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients diagnosed with adenomyosis and/or chocolate cysts, suspected infertility with endometriosis, and proposed for laparoscopic surgery at our hospital. Sexual life history. Surgery was performed within 2 months of the examination. Subjects volunteered to participate in the study and signed the informed consent form. Exclusion Criteria: colporrhagia. Acute inflammation of reproductive system. Allergic to ultrasound contrast agent (Sonovue). Suspected malignant lesions of cervix or uterine cavity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| conventional transvaginal ultrasound group<br> | |
| double contrast-enhanced ultrasound group<br>perfromed hysterosalpingo-contrast sonography and sonoPODography examination | Diagnostic Test: Hysterosalpingo-contrast sonography and sonoPODography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True positive rate | According to the #Enzian classification system, the proportion of the number of DE lesions found by double contrast-enhanced ultrasound (DCEUS) in the pelvic cavity to the number of DE lesions found by laparoscopy. | Surgery was performed within 2 months of the examination | 
| True negative rate | According to the #Enzian classification system, the proportion of pelvic normal numbers shown by DCEUS to the number of pelvic normal numbers show by laparoscopy. | Surgery was performed within 2 months of the examination | 
| False negative rate | According to the #Enzian classification system, the proportion of pelvic DE lesions that were not detected by DCEUS in pelvic DE lesions. | Surgery was performed within 2 months of the examination | 
| False positive rate | According to the #Enzian classification system, in the non-pelvic DE lesions, the proportion of the number of DE lesions diagnosed by pelvic dual contrast-enhanced ultrasound accounted for. | Surgery was performed within 2 months of the examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep endometriosis, contrast-enhanced ultrasound, #Enzian classification, preoperative evaluation