Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Temporary Uterine Tourniquet Application, Local Myometrial Epinephrine Injection.
- Who it may be relevant to
- Registry conditions: Laparoscopic Myomectomy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure 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 - Procedure 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.
Primary outcome measures
- Intraoperative Blood Loss [Time frame: During operation]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Minia advanced laparoscopy unit — Minya
Identifiers
NCT: NCT07525687 · 1706-9-2025