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Compares treatment options for Laparoscopic Myomectomy
Official title Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy
ClinicalTrials.gov ID: NCT07525687
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join 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.
You likely can't join 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Minya, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minya, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.