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Clinical Trials in Egypt / NCT07525687
Recruiting Not applicable

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

NCT07525687 · tracked via the Priya Life Science Egypt tracker
Sponsor
Minia University
Phase
Not applicable
Started
2026-04-20
Last updated
2026-07-21

Condition(s) studied

Laparoscopic Myomectomy

Investigational drug(s) / intervention(s)

Temporary Uterine Tourniquet ApplicationLocal Myometrial Epinephrine Injection

Temporary 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

Local 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.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • Intraoperative Blood Loss — During operation

Trial sites (1)

FacilityCityRegionStatus
Minia advanced laparoscopy unit Minya Egypt Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07525687 on ClinicalTrials.gov ↗ ← All trials in Egypt