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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMinia University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Temporary Uterine Tourniquet Application

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

37 Participants
are divided into 2 treatment groups
Group A: Temporary Uterine Tourniquet ApplicationActive comparator 1 intervention
Group B: Local Myometrial Epinephrine InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative Blood Loss

Time frame
During operation

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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