Evaluating deep endometriosis with advanced ultrasound techniques before surgery
Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis: a Prospective Diagnostic Test
This study is testing new ultrasound techniques to see if they can better identify deep endometriosis in women with adenomyosis or chocolate cysts before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Shenzhen Second People's Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05540821 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of double contrast-enhanced ultrasound techniques, specifically Hysterosalpingo-contrast sonography and sonoPODography, in the preoperative evaluation of deep endometriosis. By utilizing the #Enzian classification system, the study seeks to provide a detailed description of deep endometriosis lesions, which is crucial for effective treatment planning. The study focuses on female patients diagnosed with adenomyosis or chocolate cysts who are scheduled for laparoscopic surgery. The goal is to improve the detection rate of deep endometriosis compared to conventional ultrasound methods.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with adenomyosis or chocolate cysts, suspected of infertility due to endometriosis, and scheduled for laparoscopic surgery.
Not a fit: Patients with acute inflammation of the reproductive system or suspected malignant lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance preoperative evaluations, leading to better surgical outcomes for patients with deep endometriosis.
How similar studies have performed: While this approach is innovative, similar studies using advanced ultrasound techniques have shown promise in improving diagnostic accuracy for endometriosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qiuxiang Chen
- Email: 616441594@qq.com
- Phone: 0755-83366388-8856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.