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Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

Recruitingn/aAges 18 Years - anyFemaleUniversitaire Ziekenhuizen KU Leuven
NCT06988280 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Adnexal cysts or pseudocysts are a common finding on transvaginal ultrasound, especially in premenopausal women. Due to the size of some cysts, they may cause discomfort. Moreover, a genuine risk of ovarian torsion presents when these lesions grow. During the last decades, great advancements have been made in the correct differentiation of benign from malignant lesions. However, there still is controversy concerning the optimal treatment approach of symptomatic adnexal cysts with a low risk of malignancy, consisting of both surgery or ultrasound-guided transvaginal aspiration. Factors such as comorbidities and lesion characteristics need to be considered when counselling patients, as well as the possibility of short term recurrence. Surgically removing them may result in longer hospital stays and recovery, with higher costs, while transvaginal needle aspiration techniques can be perfor

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📋 Eligibility rules (as published)
Participants eligible for inclusion in this study must meet all of the following criteria: 1. Lesion criteria applicable for therapeutic intervention 1. Safe accessibility of the lesion (within reach of aspiration needle; visible on ultrasound; transvaginal access; no interposition of bowel or blood vessels) 2. Lesion types included: cystic lesions (adnexal cysts), pelvic inclusion cysts (pseudocysts), pelvic abscesses 2. Indications 1. Pain relief in symptomatic cystic lesions with benign appearance. 2. Symptomatic treatment in probably malignant lesions (only in non-curative setting). Exclusion Criteria: 1. Patients \<18 years 2. Poor performance status contra-indicating the procedure 3. Vaginal stenosis (severe atrophy - virgo - vaginismus) 4. Purely solid lesions 5. Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting 6. Physiological cysts in asymptomatic patients (in case of doubt the patient is reassessed after 3-6 months)
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What it tests

  • Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.
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Where

1 site
University Hospitals Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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