A Randomized Controlled Trial of High-Intensity Focused Ultrasound (HIFU) Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change of quality of life by Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL) from baseline to 3 months after HIFU or myomectomy
研究概览
简要总结
The goal of this clinical trial is to learn if High-Intensity Focused Ultrasound (HIFU) is as effective as myomectomy for treating symptomatic uterine fibroids in women aged 18 to 50. The main questions it aims to answer are:
Is HIFU as effective as myomectomy in improving quality of life for women with uterine fibroids? How do the recovery times and complications compare between HIFU and myomectomy? Researchers will compare the outcomes of women receiving HIFU treatment to those undergoing myomectomy to see if HIFU offers similar or better results with fewer complications.
Participants will:
Undergo an initial medical assessment, including ultrasounds and blood tests. Receive either HIFU treatment or myomectomy based on random assignment. Complete questionnaires about their symptoms and quality of life before treatment and at follow-up visits (3 and 6 months post-treatment).
Be monitored for any complications and recovery progress during follow-up.
详细描述
This multicenter, randomized controlled trial (RCT) aims to compare the effectiveness, safety, and quality of life impacts between HIFU and myomectomy in treating symptomatic uterine fibroids. The study will adhere to the International Council for Harmonisation's Good Clinical Practice (ICH-GCP) guidelines and the Declaration of Helsinki.
Recruitment and Baseline Characteristics:
Women aged 18 to 50 who present with symptomatic uterine fibroids will be recruited from gynecology clinics within the New Territories East Cluster (NTEC) and Kowloon East Cluster (KEC). The recruitment process will involve a thorough review of participants' gynecological and medical histories, physical examinations, blood tests and imaging studies to assess fibroid characteristics.
All participants will be invited to fill in the Chinese validated Uterine Fibroid Symptom and Health-related Quality of Life questionnaire (UFS-QOL), Short Form-12 questionnaire (SF-12); and Pictorial Blood loss Assessment Chart (PBAC) to document menstrual cycles and any dysmenorrhea experienced.
Randomization:
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
- None
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
- •Age 18 - 50 years-old
- •Pre or peri menopausal with FSH less than 25 mIU/ml
- •BMI < 33 kg/m2 or abdominal wall thickness < 5 cm
- •Uterine size ≤18 weeks based on physical exam assessment
- •Dominant intramural fibroid ≥ 3cm and ≤ 10cm on imaging
- •Symptomatic fibroids cause menorrhagia, pressure, or pelvic pain
- •Willing and able to give informed consent
排除标准
- •Patient with other pelvic mass indicated by history or magnetic resonance imaging (MRI) such as endometriosis, abnormal adnexal mass, ovarian tumor, acute or chronic pelvic inflammatory disease
- •Morbid obesity
- •Inability to lie in a prone position for more than 2 hours
- •Extensive abdominal scar on the acoustic channel
- •Women with pregnancy, lactation or menopause
- •Uterine premalignant or malignant pathologies or pathology other than uterine fibroid cannot be ruled out through detailed clinical assessment and investigation including MRI
- •Rapid growth of fibroids, defined as a doubling in size in 6 months
- •History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
- •Coagulation problem or using medication which affect clotting function
- •History of pelvic irradiation
- •Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter
- •Cervical/ broad ligament fibroid
- •Contraindication to MRI due to severe claustrophobia or implanted metallic device.
- •Co-existing adenomyosis
研究组 & 干预措施
HIFU group
All women in the HIFU group will undergo pelvic MRI scans, including T1- and T2-weighted imaging, for fibroid localization and treatment planning. The HIFU treatment will utilize the Haifu JC 200 system under real-time ultrasound guidance, with participants positioned prone in a water-filled generator chamber. Conscious sedation will be administered using fentanyl and midazolam, adjusted based on pain tolerance. Acoustic output power will range from 300 to 400W, with treatment energy tailored to participant feedback and ultrasound imaging.
Post-procedure, participants will be monitored for 4-6 hours, with discharge criteria including dietary tolerance and urination. Data on pain, skin condition, and adverse events will be collected.
Before discharge, participants will complete a Client Satisfaction questionnaire and will receive analgesics, along with instructions to document menstrual cycles using the PBAC chart.
干预措施: High-Intensity Focused Ultrasound (HIFU) (Procedure)
Myomectomy group
Myomectomy will be performed using laparoscopic, open, or hysteroscopic techniques by accredited HKCOG gynecologists.
Key metrics such as blood loss, intraoperative and postoperative complications, whether the endometrial cavity was entered, length of hospital stay, need for blood transfusion, and readmissions will be meticulously recorded. A complete blood count will be assessed approximately 6 hours post-surgery. Patients will be monitored for blood pressure and pulse per departmental protocol.
Typically, those undergoing hysteroscopic myomectomy are discharged the same day, while laparoscopic or open myomectomy patients are discharged within 1 to 3 days.
Before discharge, women will complete a Client Satisfaction questionnaire and will receive analgesics, along with instructions to document their menstrual cycle, flow, and dysmenorrhea using the PBAC chart.
干预措施: myomectomy (Procedure)
结局指标
主要结局
Change of quality of life by Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL) from baseline to 3 months after HIFU or myomectomy
时间窗: From enrollment to the end of treatment at 3 months
The efficacy of treatment using the Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL), changes from baseline to 3 months post-treatment
Change of quality of life by Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL) from baseline to 6 months after HIFU or myomectomy
时间窗: From enrolment to the end of treatment at 6 months
The efficacy of treatment using the Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL), changes from baseline to 6 months post-treatment
次要结局
- Change of health-related quality of life by Short Form-12 questionnaire (SF-12) from baseline to 3 months after HIFU or myomectomy(From enrolment to the end of treatment at 3 months)
- Change of health-related quality of life by Short Form-12 questionnaire (SF-12) from baseline to 6 months after HIFU or myomectomy(From enrolment to the end of treatment at 6 months)
- Change of Pictorial Blood loss Assessment Chart (PBAC) score from baseline to 3 months after HIFU or myomectomy(From enrolment to the end of treatment at 3 months)
- Change of Pictorial Blood loss Assessment Chart (PBAC) score from baseline to 6 months after HIFU or myomectomy(From enrolment to the end of treatment at 6 months)
- Change of scores by Client Satisfaction questionnaire (CSQ-8) from baseline to 3 months after HIFU or myomectomy(From enrolment to the end of treatment at 3 months)
- Change of scores by Client Satisfaction questionnaire (CSQ-8) from baseline to 6 months after HIFU or myomectomy(From enrolment to the end of treatment at 6 months)
- Change of haemoglobin from baseline to 3 months after HIFU or myomectomy(From enrolment to the end of treatment at 3 months)
- Change of haemoglobin from baseline to 6 months after HIFU or myomectomy(From enrolment to the end of treatment at 6 months)
- Change of fibroid volume from baseline to 3 months after HIFU or myomectomy(From enrolment to the end of treatment at 3 months)
- Change of fibroid volume from baseline to 6 months after HIFU or myomectomy(From enrolment to the end of treatment at 6 months)
研究者
CHAN SYMPHOROSA SHING CHEE
Consultant and Honorary Clinical Professor
Chinese University of Hong Kong