Effects of Different Intraoperative Bleeding Control Methods on Haematological Outcomes and the Amount of Bleeding in Open Myomectomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
Excessive intraoperative bleeding remains a major challenge during open myomectomy and may lead to postoperative anemia and increased morbidity. Numerous methods have been proposed to minimize hemorrhage; however, evidence regarding their effectiveness in open surgery remains limited.
This prospective randomized controlled trial aims to evaluate the effects of tourniquet application, uterine artery bulldog clamping, and no-compression techniques on intraoperative blood loss and postoperative hematological parameters in patients undergoing open myomectomy.
A total of 120 patients undergoing open myomectomy will be randomly assigned to three groups: tourniquet group (n = 40), uterine artery bulldog clamp group (n = 40), and no-compression group (n = 40). The primary outcome is intraoperative blood loss. Secondary outcomes include hemoglobin (Hb) and hematocrit (Hct) levels at 24 and 48 hours postoperatively. Myoma volume will be calculated using the spherical formula based on the maximum myoma diameter. Statistical analyses will be performed using one-way analysis of variance (ANOVA) or the Kruskal-Wallis test, as appropriate.
详细描述
This prospective randomized controlled trial aims to evaluate the effectiveness of different intraoperative bleeding control techniques during open myomectomy. Uterine leiomyomas are highly vascular tumors, and excessive intraoperative bleeding remains a major challenge, potentially leading to postoperative anemia and increased morbidity.
Various strategies have been developed to reduce intraoperative blood loss, including mechanical and surgical methods aimed at temporarily reducing uterine arterial blood flow. However, most available evidence focuses on minimally invasive approaches, and data regarding open myomectomy remain limited.
In this study, patients undergoing open myomectomy will be randomized into three groups according to the intraoperative bleeding control method: tourniquet application, bilateral uterine artery occlusion using bulldog clamps, and no compression. All procedures will be performed using a standardized surgical technique.
The study aims to compare these techniques in terms of intraoperative blood loss and postoperative hematological parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the surgical interventions, blinding of participants and care providers was not feasible. However, outcome assessors and data analysts were blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 50 years
- •Diagnosis of symptomatic uterine leiomyoma
- •Planned abdominal (open) myomectomy
- •No additional surgical procedure performed during the operation
- •Availability of complete preoperative and postoperative laboratory data
排除标准
- •Pregnancy or suspected pregnancy
- •Presence of more than 7 myomas
- •Suspicion or diagnosis of uterine malignancy
- •History of coagulopathy or use of anticoagulant/antiplatelet therapy
- •Preoperative blood transfusion
- •Concomitant major surgical procedures (e.g., hysterectomy or adnexal surgery)
- •History of previous myomectomy
- •Incomplete laboratory or clinical data
研究组 & 干预措施
Tourniquet group
Participants undergoing open myomectomy in whom an elastic surgical tourniquet was applied at the level of the lower uterine segment/cervix to temporarily reduce uterine blood flow during surgery.
干预措施: Tourniquet application (Procedure)
Bulldog clamp group
Participants undergoing open myomectomy in whom bilateral uterine arteries were dissected and temporarily occluded using bulldog clamps during surgery to control intraoperative bleeding.
干预措施: Uterine artery bulldog clamp (Procedure)
No-compression group
Participants undergoing open myomectomy without the use of any mechanical or surgical compression technique for uterine arteries; standard surgical procedures were applied.
结局指标
主要结局
Intraoperative blood loss
时间窗: During Surgery
Intraoperative blood loss measured in milliliters by calculating the difference between the weight of dry and blood-soaked surgical materials and the volume of blood collected in the suction canister.
次要结局
- Postoperative hemoglobin level(24 and 48 hours after surgery)
- Postoperative hematocrit level(24 and 48 hours after surgery)
- Operative time(During surgery)
研究者
Onur Karaaslan
Assoc. Professor
Yuzuncu Yil University