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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05540821
Enrollment
156
Registered
2022-09-15
Start date
2022-06-01
Completion date
2025-06-30
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Endometriosis

Keywords

Deep endometriosis, contrast-enhanced ultrasound, #Enzian classification, preoperative evaluation

Brief 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.

Interventions

DIAGNOSTIC_TESTHysterosalpingo-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.

Sponsors

Shenzhen Second People's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
True positive rateSurgery was performed within 2 months of the examinationAccording 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.
True negative rateSurgery was performed within 2 months of the examinationAccording to the #Enzian classification system, the proportion of pelvic normal numbers shown by DCEUS to the number of pelvic normal numbers show by laparoscopy.
False negative rateSurgery was performed within 2 months of the examinationAccording to the #Enzian classification system, the proportion of pelvic DE lesions that were not detected by DCEUS in pelvic DE lesions.
False positive rateSurgery was performed within 2 months of the examinationAccording 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.

Countries

China

Contacts

Primary ContactQiuxiang Chen
616441594@qq.com0755-83366388-8856

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026