NCT06692335 | NOT YET RECRUITING | Uterine Fibroids (UF)

Detailed Description:

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: Participants meeting the inclusion criteria will be consented and randomized in a 1:1 ratio to either the HIFU group or the myomectomy group via permuted-block randomization. Randomization will be conducted by a research assistant using sealed, opaque envelopes containing computer-generated treatment assignments. Interventions: HIFU Protocol: Pre-Treatment Imaging: All participants in the HIFU group will undergo a pelvic MRI for localization and assessment of fibroids. HIFU Treatment: The Haifu JC 200 Focused Ultrasound Tumor Therapeutic System will be employed. Participants will lie in a prone position with their lower abdomen submerged in degassed water. Conscious sedation will be achieved using fentanyl and midazolam, adjusted per participant feedback during the procedure. Postoperative Care and Discharge Planning: After treatment, patients will be observed for 4-6 hours in the ward for any immediate side effects, with discharge criteria based on their ability to tolerate food and mobilize. Myomectomy Surgical Approach: Myomectomy will be conducted using laparoscopic, open, or hysteroscopic techniques. Intraoperative Monitoring: Key metrics such as blood loss, complications, and whether the endometrial cavity is entered will be meticulously recorded. Postoperative Care and Discharge Planning: Patients will be monitored according to the department's protocol, with blood tests performed at approximately 6 hours post-surgery to evaluate hemoglobin levels. Similar to the HIFU group, women will be discharged with analgesics and instructed to document their menstrual symptoms. Post-Procedure Documentation: Baseline characteristics, pain levels, skin condition, neurological symptoms, and other adverse events will be documented. All participants will be asked to fill in the Client Satisfaction Questionnaire (CSQ-8) and PBAC. Follow-Up Procedures: All participants will be followed up by a telephone interview at 2 weeks, and a face-to-face assessment at 3 months and 6 months post-treatment. During these clinical visits, vital signs will be monitored, and participants will complete the UFS-QOL, SF-12, and CSQ-8. Investigators blinded to group assignments will perform physical assessments and ultrasound scans to evaluate uterine size and fibroid volume. Data Processing and Analysis: Data analysis will be conducted using SPSS 29.0. An intention-to-treat approach will be employed. Categorical data will be analyzed using Chi-square or Fisher exact tests. Continuous variables will be assessed using appropriate t-tests or non-parametric equivalents. Both univariate and multivariate analyses will be used to identify factors associated with treatment outcomes. Hypothesis: The findings from this RCT could significantly impact clinical practice by offering a less invasive treatment alternative for women with symptomatic uterine fibroids, potentially leading to improved quality of life and fertility preservation. The study's comprehensive design and rigorous methodology aim to address existing gaps in the literature regarding the effectiveness and safety of HIFU compared to traditional surgical approaches.