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Gonadotropin-releasing hormone agonist versus expectant management for treating multiple leiomyomas after myomectomy: the study protocol for a multicentre, prospective, randomised controlled clinical trial

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机构: [1]Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China [2]Obstetrics and Gynaecology, Shenzhen Second People’s Hospital, Shenzhen, Guangdong, China [3]Obstetrics and Gynaecology, Wuhan University Zhongnan Hospital, Wuhan, Hubei, China [4]Obstetrics and Gynaecology, Wuhan University Renmin Hospital, Wuhan, Hubei, China [5]Obstetrics and Gynaecology, Three Gorges University Renhe Hospital, Yichang, Hubei, China [6]Obstetrics and Gynaecology, Xiangyang Central Hospital, Xiangyang, Hubei, China [7]Obstetrics and Gynaecology, Maternal and Child Hospital of Hubei Province, Wuhan, Hubei, China [8]Obstetrics and Gynaecology, First People’s Hospital of Yunnan, Kunming, Yunnan, China [9]Obstetrics and Gynaecology, Zhengzhou University First Affiliated Hospital, Zhengzhou, Henan, China [10]Obstetrics and Gynaecology, Taihe Hospital, Shiyan, Hubei, China [11]Obstetrics and Gynaecology, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, Henan, China [12]Obstetrics and Gynaecology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
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关键词: gynaecology protocols & guidelines clinical trials

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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.

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出版当年[2021]版:
大类 | 4 区 医学
小类 | 3 区 医学:内科
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
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出版当年[2020]版:
Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
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