IDEAL (Idea, Development, Exploration, Assessment, and Long-term Follow-up) Research - Evidence-Based Medicine for HIFU Treatment of Uterine Fibroids in 2411 Cases

Common treatments for patients with uterine fibroids include: myomectomy,hysterectomy,HIFU, etc. Patients may have heard of these types of treatments but still know only a smattering.

What are the differences? Which one is better in terms of safety, efficiency, quality and economic benefits? 

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During the “Twelfth Five-year Plan” period, supported by the Ministry of Science and Technology (MOST) and National Key Technology R&D Program, an IDEAL research of ultrasound ablation of uterine fibroids, led by Academician of Chinese Academy of Engineering Jinghe Lang, presented the most persuasive clinical data ever to us. After 5 years of work by 20 hospitals nationwide, the results were examined by the Ministry of Science and Technology, and published in the British Journal of Obstetrics and Gynecology (BJOG), the world's top influential obstetrics and gynecology journal.

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Research Purpose:

To evaluate the clinical results of high-intensity focused ultrasound and surgical treatment of uterine fibroids, and provide evidences for a randomized clinical trial.

Research Design:

To conduct a comparison between the therapeutic effect of HIFU, myomectomy and hysterectomy in patients with symptomatic uterine fibroids by means of IDEAL research.

Research Site & Population:

20 hospitals in China & 2411 patients with symptomatic uterine fibroids.

Research Results:

A total of 2411 patients participated in the research, of which 1353 underwent HIFU; 472 underwent hysterectomy, and the rest 586 underwent myomectomy.

Compared with those who underwent surgery, patients treated with HIFU were far younger (p<0.001) and thinner (p<0.001); they also had higher education level and better economic condition. (p=0.002).

Both UFS and QoL (a scale reflecting quality of life) improved more rapidly after the HIFU treatment (p=0.002 and p=0.001, respectively, in the sixth month of post-treatment and pre-treatment), but the absolute difference was little.

The number of severe complications in HIFU was 3 (0.2%), while the one in surgery was 133 (12.6%) (p<0.001).

The length of stay for each of the three surgical procedures was 4 days for HIFU (inter-quartile range: 0-5 days), 10 days for hysterectomy (inter-quartile range: 8-12.5 days), and 8 days for myomectomy (inter-quartile range: 7-10 days).

Conclusion:

Compared with surgery for uterine fibroids, high-intensity focused ultrasound promises a similar long-term postoperative quality of life but with less length of stay and side effects.