About this trial
While both local vasoconstrictors and tourniquet application are recognized methods for blood loss control, there is a paucity of head-to-head randomized controlled trials directly comparing these two distinct approaches in laparoscopic myomectomy. Existing data often compare these methods to no intervention or to other less common techniques. A direct comparison is essential to determine which method offers superior hemostasis with an acceptable safety profile in the laparoscopic setting. This study aims to address this gap in the literature.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18-45 years.
Diagnosed with symptomatic uterine leiomyomas requiring laparoscopic myomectomy.
Presence of at least one myoma with a diameter ≥3 cm and ≤10 cm.
Patients with up to 3 myomas (to standardize surgical complexity).
Disqualifiers
Patients with more than 3 myomas or any myoma larger than 10 cm.
Patients with suspected uterine malignancy (e.g., leiomyosarcoma).
Patients with known bleeding disorders or on anticoagulant therapy that cannot be safely discontinued.
Patients with significant cardiovascular disease, uncontrolled hypertension, or arrhythmias (relative contraindications for epinephrine).
Trial design
Parallel
Treatments tested in this trial
Temporary Uterine Tourniquet Application
Procedure/SurgeryThe tourniquet will be tightened just enough to achieve visible blanching of the uterus, indicating adequate vascular occlusion, but without excessive tension to avoid tissue damage
Local Myometrial Epinephrine Injection
Procedure/SurgeryApproximately 5-10 mL of the diluted epinephrine will be injected into the myometrium surrounding each fibroid, specifically at the base of the myoma and along the planned incision line, using a laparoscopic injection needle.
Treatment groups
Trial outcomes
Primary outcomes
Intraoperative Blood Loss
Locations
Sponsors and contacts
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