Laparoscopic Myomectomy
Conditions
Brief 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.
Interventions
PROCEDURETemporary Uterine Tourniquet Application
The 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
PROCEDURELocal Myometrial Epinephrine Injection
Approximately 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.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative Blood Loss | During operation |
Countries
Egypt
Outcome results
None listed