Gonadotropin-releasing hormone agonist versus expectant management for treating multiple leiomyomas after myomectomy: the study protocol for a multicentre, prospective, randomised controlled clinical trial
Lin Li,
Xin Du,
Wei Zhang,
Jia Wei,
Li Hong,
Shixuan Wang,
Ruixia Guo,
Minli Zhang,
Xiangyi Ma,
Wenwen Wang,
Zhiying Yu,
Zhiying Li,
Yun Feng,
Chunlian Zhang,
Qingfen Yue,
Wuliang Wang
Affiliations
Lin Li
Obstetrics and Gynaecology, Xiangyang Central Hospital, Xiangyang, Hubei, China
Xin Du
Heart Health Research Centre, Beijing, China
Wei Zhang
Centre for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, Canada
Jia Wei
Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Li Hong
Obstetrics and Gynaecology, Wuhan University Renmin Hospital, Wuhan, Hubei, China
Shixuan Wang
Department of Obstetrics and Gynecology, National Clinical Research Center for Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Ruixia Guo
Obstetrics and Gynaecology, Zhengzhou University First Affiliated Hospital, Zhengzhou, Henan, China
Minli Zhang
Department of Obstetrics and Gynecology, National Clinical Research Center for Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Xiangyi Ma
Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Wenwen Wang
Department of Obstetrics and Gynecology, National Clinical Research Center for Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Zhiying Yu
Obstetrics and Gynaecology, Shenzhen Second People’s Hospital, Shenzhen, Guangdong, China
Zhiying Li
Obstetrics and Gynaecology, Three Gorges University Renhe Hospital, Yichang, Hubei, China
Yun Feng
School of Nursing, Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China
Chunlian Zhang
Obstetrics and Gynaecology, Taihe Hospital, Shiyan, Hubei, China
Qingfen Yue
Obstetrics and Gynaecology, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, Henan, China
Wuliang Wang
Obstetrics and Gynaecology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Introduction Leiomyoma recurrence is a major concern for long-term myomectomy management, especially for multiple leiomyomas. Gonadotropin-releasing hormone agonist (GnRHa) is one of the most effective medications to reduce the volume of fibroids and the uterus. However, its role in preventing recurrence after conservative surgery remains unclear. At present, there is no randomised clinical trial determining the efficacy of GnRHa treatment for preventing multiple leiomyomas recurrence after myomectomy.Methods and analysis We are conducting a phase IV randomised controlled trial in women aged 18–45 undergoing myomectomy for multiple leiomyomas. After surgery, women whose pathological result confirms multiple leiomyomas are randomised in a 1:1 ratio into an observation or GnRHa group. The primary outcome is the recurrence of either clinical symptoms or fibroids on imaging. Patients will be assessed for adverse events during the follow-up.Ethics and dissemination The study was approved by the Medical Ethics Committee of the Tongji Hospital Affiliated with the Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20180311) according to the submitted study protocol (V.1.0, 10 November 2017) and informed consent (V.1.0, 10 November 2017). The results will be presented at domestic and international conferences and published in peer-reviewed journals.Trial registration number ChiCTR-IPR-17012992.
