Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Intraoperative Blood Loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Local Myometrial Epinephrine Injection
干预措施: Local Myometrial Epinephrine Injection (Procedure)
Temporary Uterine Tourniquet Application
干预措施: Temporary Uterine Tourniquet Application (Procedure)
结局指标
主要结局
Intraoperative Blood Loss
时间窗: During operation
次要结局
未报告次要终点
研究者
Mohamed Hassan Mohamed Abdel Ghfar
Lecturer of Obstetrics and Gynecology
Minia University