Investigation of the Impact of Myomectomy on Uterine Artery Doppler Velocimetry Findings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pulsatility index
研究概览
简要总结
Objective: This scientific study aims to investigate whether myomectomy induces significant changes in uterine artery blood flow patterns. While Doppler ultrasonography is traditionally used to assess myoma vascularity, differential diagnosis (adenomyoma or sarcoma), and fertility impacts, there is a lack of prospective evidence comparing preoperative and postoperative uterine artery Doppler findings.
Study Design and Rationale: The study will evaluate the hemodynamic influence of myomectomy by comparing flow measurements in the main uterine artery before and after surgical intervention. Existing literature has primarily focused on the correlation between myoma volume and vascular resistance; however, the direct impact of surgical removal of a myoma on uterine artery doppler velocimetry remains under-investigated.
Participant Involvement: Participation is entirely voluntary, and participants may withdraw at any time without any impact on their medical care. Data collection involves routine clinical history, physical examination, and non-invasive ultrasound measurements.
Clinical Significance: By establishing the effect of myoma removal on uterine blood supply, this research aims to provide guiding data for the follow-up and treatment planning of patients with leiomyomas. The findings may offer new insights into how surgical management restores or alters uterine hemodynamics, potentially influencing future diagnostic and therapeutic approaches.
详细描述
Uterine leiomyomas are the most common benign pelvic tumors in women and originate from the uterine smooth muscle tissue. While often asymptomatic, their size and location can cause clinical symptoms that significantly impair quality of life.
The pathogenesis of uterine leiomyoma is yet to be elucidated by the ongoing research. Our current knowledge reveals myoma pathogenesis involves a complex interplay of genetic factors, sex steroids, growth factors, extracellular matrix interactions, and angiogenesis. Understanding the mechanisms of leiomyoma pathogenesis and the interaction of myoma with adjacent myometrium is crucial to improve our management and treatment options.
Ultrasonography (USG) remains the gold standard for first-line imaging for uterine leiomyomas being highly sensitive, specific, and cost-effective. Doppler USG enables the evaluation of uterine blood flow by measuring the pulsatility index (PI), resistance index (RI), and systole/diastole (S/D) ratio. These parameters are widely used in routine obstetrics practice, where higher values indicate increased distal vascular resistance and lower values reflect enhanced perfusion and reduced impedance. Several studies observed increased blood flow in uterine artery measuring significantly lower resistance in the vessel. Our previous study revealed different doppler velocimetry findings in different leiomyoma localizations and a positive correlation between the indices and uterine operation history indicating an increased resistance in uterine artery after uterine surgery.
Myomectomy is a common procedure for cases of symptomatic leiomyoma and widely performed by gynecologists. This study aims to investigate the impact of myomectomy on uterine artery Doppler velocimetry parameters by comparing preoperative and postoperative measurements in patients diagnosed with uterine leiomyoma.
Method: This single-center, prospective clinical study will be conducted at the Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Obstetrics and Gynecology, between August 2025 and January 2026. Following ethical approval, patients scheduled for myomectomy will be screened based on specific inclusion and exclusion criteria. Written informed consent will be obtained from all voluntary participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women aged between 18 and 50 years.
- •Women with uterine leiomyoma detected via ultrasonography.
- •Patients referred to the Obstetrics and Gynecology department board for whom a myomectomy operation has been decided.
- •Women who provide consent for transvaginal ultrasound examination.
排除标准
- •Women under 18 years of age and postmenopausal women.
- •Current pregnancy or postpartum status.
- •Presence of known circulatory disorders, cardiovascular diseases, or other chronic conditions affecting blood flow.
- •Current use of hormonal medications (e.g., oral contraceptives, levonorgestrel-releasing intrauterine devices, etc.).
- •Presence of concurrent gynecological pathologies (e.g., adenomyosis, endometriosis, ovarian cysts, or gynecological malignancies).
结局指标
主要结局
Pulsatility index
时间窗: from the enrollment in preoperative period to the late postoperative period (40 days after operation)
Pulsatility index will be measured in bilateral uterine arteries preoperatively and postoperatively in myomectomy cases.
resistance index
时间窗: from the enrollment in preoperative period to the late postoperative period (40 days after operation)
Uterine arter doppler measurement of resistance index will be measured preoperatively and postoperatively (40 days after operation) for bilateral uterine arteries.
systolic/dyastolic ratio
时间窗: from the enrollment in preoperative period to the late postoperative period (40 days after operation
Systolic/dyastolic ratio will be measured in bilateral uterine arteries preoperatively and postoperatively in myomectomy cases.
次要结局
未报告次要终点
研究者
İlke Esin Aydıner
M.D.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital