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

NCT07525687 | Not Yet Recruiting

• 1 other identifier: 1706-9-2025
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Laparoscopic Myomectomy

Outcome Measures

Primary Outcomes (1)

• Intraoperative Blood Loss

  During operation

Study Arms (2)

Temporary Uterine Tourniquet Application

ACTIVE COMPARATOR

Procedure: Temporary Uterine Tourniquet Application

Local Myometrial Epinephrine Injection

ACTIVE COMPARATOR

Procedure: Local Myometrial Epinephrine Injection

Interventions

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.

Local Myometrial Epinephrine Injection

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

Temporary Uterine Tourniquet Application

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04