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Recruiting NCT07525687

Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy

Conditions: Laparoscopic Myomectomy

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 74
Sponsor: Minia University

Location: Minia advanced laparoscopy unit Minya

Summary

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

Inclusion Criteria: * 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). * Preoperative hemoglobin level ≥10 g/dL. * Ability to provide informed consent. Exclusion Criteria: * 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). * Patients with active pelvic infection. * Patients with previous extensive uterine surgery (e.g., multiple prior myomectomies or extensive uterine reconstruction) that may compromise uterine integrity. * Patients undergoing concurrent major gynecological procedures that might significantly affect blood loss (e.g., hysterectomy, extensive adhesiolysis). * Patients with known allergy to epinephrine. * Patients unwilling or unable to comply with follow-up protocols.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07525687). StuddyBuddy aggregates publicly available trial information.