A Pilot study comparing efficacy of Uterine artery embolisation vs hysterectomy in patients with symptomatic uterine fibroids.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fibroid size as assessed by USG or MRI
研究概览
简要总结
Uterine myomas are benign uterine neoplasms that arise from the smooth muscle of uterus. They constitute the most common benign gynecological tumors affecting 20-50% of women of reproductive age group, thirty percent of these presenting with menstrual abnormality and menorrhagia being most common (1). Other presenting symptoms include pelvic pain (34%), infertility (27%) and pelvic mass (9%) (1). Occasionally they are associated with bladder and bowel pressure symptoms.
Uterine fibroids may occur singly but most often are multiple and vary in size from an unnoticeable few millimetres to over 20 cm in diameter, significantly enlarging the abdominal cavity. They are named according to their location. Intramural fibroids lie wholly within the uterine walls, submucosal fibroids project into the uterine cavity and subserosal fibroids project from the outer surface of the uterus. They may also be pedunculated, where they are attached to the uterine wall by a stalk-like structure.
Most of the myomas are asymptomatic and does not require treatment until symptomatic or causing infertility. The management of symptomatic fibroids has traditionally been surgical; however, alternative pharmacological treatments have been proposed to control symptoms. The choice of appropriate therapeutic approach depends on several factors including: age, parity, childbearing aspirations, extent and severity of symptoms, size, number, location of myomas, proximity to menopause.
Ravina et al (2) first reported transcatheter embolization of the uterine arteries for treatment of uterine leiomyomata in 1995. The safety and efficacy of the procedure have been extensively studied, and UFE is now accepted as a treatment option for fibroids by the American Congress of Obstetricians and Gynecologists (3). UFE has been shown to reduce pain, bulk symptoms (pressure and abdominal wall distortion), and menorrhagia in most cases (4). Although hysterectomy has long been considered the definitive treatment for symptomatic fibroids and remains the most common intervention for fibroids, there is growing interest in less invasive therapies and treatments that avoid removal of the uterus, including medical management, abdominal or laparoscopic myomectomy, endometrial ablation, focused US, and UFE (5). Uterine embolization has emerged as one of the most important of these uterine-sparing options.
Uterine artery embolization (UAE) involves complete occlusion of either one or both uterine arteries with particulate emboli to cause ischaemic necrosis of the uterine fibroids. The closure of the arteries is considered permanent, thereby blocking blood supply to the fibroid but without any permanent adverse effect on the otherwise normal uterus.
Since there are studies that Uterine artery embolization may cause a reduction in the reproductive potential of women as compared to a laparoscopic myomectomy and also it might predispose nulliparous women to placental abnormalities, we plan to use it only for women who have completed their family and seek treatment for bleeding, pain and pressure symptoms.
Given its minimally invasive nature, established favorable cost profile, and associated rapid recovery and return to work, UAE should be considered a front-line therapy for leiomyomata and should therefore be presented to all patients as an option for symptomatic leiomyomas. With this background, we plan to study the therapeutic effect of uterine artery embolization for treating symptomatic fibroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- Female
入选标准
- •Menstruating women with symptomatic uterine fibroids who have completed their family Uterus size≤ 24 weeks on bimanual examination.
- •Ultrasonography suggestive ofat least one uterine myoma of ≥ 3 cm diameter in size.
排除标准
- •1.Uterine size > 24 weeks on clinical examination.
- •Patients can also be taken up for UAE post trial of GnRH agonists if the fibroid
- •size at presentation is more than 12 cm at initial presentation 4.Active pelvic infection or pregnancy 5.Suspected or known case of gynecological cancer/atypical endometrial hyperplasia.
- •Known case of uncontrolled coagulation disorder, renal insufficiency, severe contrast allergy
- •Large uterine polyp (>2 cm), Submucosal fibroid (class 0 & 1 under myoma sub-classification system)
- •Large subserosal fibroids with narrow stalk.
结局指标
主要结局
Fibroid size as assessed by USG or MRI
时间窗: 6 months after treatment
Uterine fibroid Quality of life assessment score
时间窗: 6 months after treatment
次要结局
- Relief of symptoms like pain, pressure symptoms and menorrhagia(Percentage necrosis of myoma on post embolization MRI)
