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NCT Number: NCT07525687

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

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.

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Key information

Conditions

Laparoscopic Myomectomy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temporary Uterine Tourniquet Application

Procedure

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

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 outcomes

  1. Intraoperative Blood Loss

    Time frame: During operation

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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