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Clinical Trials/NCT05540821
NCT05540821
Recruiting
Not Applicable

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

Shenzhen Second People's Hospital1 site in 1 country156 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Endometriosis
Sponsor
Shenzhen Second People's Hospital
Enrollment
156
Locations
1
Primary Endpoint
True negative rate
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
June 30, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Shenzhen Second People's Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

True negative rate

Time Frame: Surgery was performed within 2 months of the examination

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.

True positive rate

Time Frame: Surgery was performed within 2 months of the examination

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.

False negative rate

Time Frame: Surgery was performed within 2 months of the examination

According to the #Enzian classification system, the proportion of pelvic DE lesions that were not detected by DCEUS in pelvic DE lesions.

False positive rate

Time Frame: Surgery was performed within 2 months of the examination

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.

Study Sites (1)

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