Bilateral Uterine Artery Ligation Versus Pericervical Mechanical Tourniquet Application in Reducing Intraoperative Blood Loss During Transabdominal Myomectomy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Estimated blood loss
研究概览
简要总结
The goal of this clinical trial is to compare two surgical techniques for reducing blood loss during transabdominal myomectomy in women with symptomatic uterine fibroids. The main question it aims to answer is whether bilateral uterine artery ligation reduces intraoperative blood loss more effectively than pericervical mechanical tourniquet application, without increasing operative complications. Researchers will compare bilateral uterine artery ligation with pericervical mechanical tourniquet application during open myomectomy to evaluate blood loss and surgical safety. Participants will undergo elective transabdominal myomectomy and will be randomly assigned to one of the two vascular control techniques before myoma enucleation.
详细描述
Uterine fibroids are among the most common benign gynecologic tumors and may cause heavy menstrual bleeding, pelvic pain, pressure symptoms, infertility, and other reproductive problems. For women who desire uterine preservation, myomectomy remains an important treatment option. In patients with large, multiple, or deeply located fibroids, transabdominal myomectomy is still widely performed. However, one of its major challenges is significant intraoperative bleeding, which may increase operative difficulty, prolong surgery, increase postoperative morbidity, and raise the need for blood transfusion.
Several methods have been used to reduce bleeding during myomectomy. Among the commonly used surgical approaches are bilateral uterine artery ligation and pericervical mechanical tourniquet application. Bilateral uterine artery ligation reduces uterine arterial inflow before myoma enucleation and may provide sustained hemostasis during surgery. Pericervical tourniquet application is a simple mechanical method that temporarily compresses the uterine vessels at the cervico-isthmic level during the procedure. Although both techniques are used in practice, comparative evidence remains limited, and further evaluation is needed to determine the more effective and safe method for blood loss reduction during fertility-sparing surgery.
This study is a prospective, randomized, comparative clinical trial conducted at the Department of Obstetrics and Gynecology, Kasr Al-Ainy Hospital, Cairo University, Egypt. Women scheduled for elective transabdominal myomectomy for symptomatic uterine fibroids will be recruited and randomized into two parallel groups. One group will undergo bilateral uterine artery ligation before myoma enucleation, while the other group will undergo pericervical mechanical tourniquet application using a Foley catheter at the level of the internal os before myoma enucleation. All procedures will be performed by the same experienced surgical team under standardized perioperative conditions to reduce inter-operator variability.
During surgery, after the assigned vascular control technique is applied, myoma enucleation and uterine repair will proceed according to a standardized operative technique. Blood loss assessment will include intraoperative blood loss measured from surgical swabs and suctioned blood, as well as postoperative blood loss measured from the intraperitoneal drain. The trial is designed to determine whether bilateral uterine artery ligation provides superior hemostatic control compared with pericervical mechanical tourniquet application, while also evaluating perioperative safety and recovery outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study is designed as a double-blind randomized clinical trial. Participants will be blinded to the assigned hemostatic technique during transabdominal myomectomy. Randomization will be performed using computer-generated allocation with sequentially numbered opaque sealed envelopes, and the allocation code will be kept by an independent supervisor. Outcome assessment and postoperative data collection will be performed without disclosure of group assignment. The operating surgical team will perform the assigned procedure intraoperatively according to the randomization code.
入排标准
- 年龄范围
- 25 Years 至 48 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Female participants aged 25 to 48 years
- •Body mass index less than 35 kg/m²
- •Symptomatic uterine myomas requiring surgical treatment
- •Intramural myomas classified as FIGO types 3 to 6
- •Diagnosis confirmed by transvaginal ultrasound and/or magnetic resonance imaging
- •Maximum diameter of the largest myoma 20 cm or less
- •Scheduled for elective transabdominal myomectomy
- •Able and willing to provide written informed consent
排除标准
- •Submucosal, intracavitary, pedunculated subserosal, cervical, or adnexal myomas
- •FIGO types 0, 1, 2, 7, or 8 myomas
- •History of pelvic inflammatory disease or peritonitis
- •Previous abdominal or pelvic surgery for non-obstetric causes
- •Previous uterine surgery
- •Use of hormonal therapy within the previous 3 months
- •Known bleeding disorder
- •Use of anticoagulant or antiplatelet therapy
- •Preoperative hemoglobin less than 10 g/dL
- •Body mass index 35 kg/m² or greater
- •Intraoperative conversion from myomectomy to hysterectomy
研究组 & 干预措施
Bilateral Uterine Artery Ligation
Participants assigned to this arm will undergo transabdominal myomectomy with bilateral uterine artery ligation performed before myoma enucleation. The uterine arteries will be identified bilaterally near the level of the internal cervical os and ligated using absorbable sutures to reduce uterine blood flow during surgery. Myoma enucleation and uterine repair will then be completed according to the study protocol.
干预措施: Bilateral Uterine Artery Ligation (Procedure)
Pericervical Mechanical Tourniquet
Participants assigned to this arm will undergo transabdominal myomectomy with application of a pericervical mechanical tourniquet before myoma enucleation. A sterile Foley catheter will be passed around the cervico-isthmic region at the level of the internal os and tied firmly to compress the uterine vessels during surgery. The tourniquet will remain in place throughout myoma enucleation and uterine repair and will be removed after completion of hemostasis.
干预措施: Pericervical Mechanical Tourniquet Application (Procedure)
结局指标
主要结局
Estimated blood loss
时间窗: During surgery and until drain removal on the second postoperative day
Total blood loss measured as the sum of intraoperative blood loss and postoperative blood loss. Intraoperative blood loss will be assessed by weighing surgical swabs and measuring suctioned blood volume, while postoperative blood loss will be measured from the intraperitoneal drain.
次要结局
- Need for blood transfusion(From surgery until hospital discharge, assessed up to 3 days.)
研究者
ahmed nagy shaker ramadan
Lecturer of obstetrics and gynecology
Cairo University
