Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial
Wenwen Wang,
Xiangyi Ma,
Wei Zhang,
Zhiying Li,
Yan Wang,
Zhiying Yu,
Chunlian Zhang,
Li Hong,
Ruoyu Luo,
Hui Xing,
Wuliang Wang,
Qingfen Yue,
Jia Wei,
Minli Zhang,
Shixuan Wang
Affiliations
Wenwen Wang
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Xiangyi Ma
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wei Zhang
Department of Obstetrics and Gynecology, Zhongnan Hospital of Wuhan University, Wuhan University
Zhiying Li
Department of Obstetrics and Gynecology, Affiliated Renhe Hospital, China Three Gorges University
Yan Wang
Maternal and Child Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology
Zhiying Yu
Department of Obstetrics and Gynecology, Shenzhen Second People’s Hospital
Chunlian Zhang
Department of Obstetrics and Gynecology, Affiliated Taihe Hospital of Hubei University of Medicine
Li Hong
Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University Hubei General Hospital
Ruoyu Luo
Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University Hubei General Hospital
Hui Xing
Department of Obstetrics and Gynecology, Xiangyang Central Hospital, Hubei University of Arts and Science
Wuliang Wang
Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Zhengzhou University
Qingfen Yue
Department of Obstetrics and Gynecology, Luoyang Central Hospital Affiliated to Zhengzhou University
Jia Wei
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Minli Zhang
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Shixuan Wang
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Abstract Background The preservation of fertility and integrity of the reproductive organs has increasingly been of concern to most women with adenomyosis. Adenomyomectomy is conservative surgery that is now widely applied; however, relapse is a serious problem after the operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the rate of disease recurrence. However, there is still a lack of evidence from randomized clinical trials examining the efficacy of GnRHa in decreasing the postoperative recurrence rate. Method/design Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse assessed using a visual analogue scale (VRS) and numeric rating scale (NRS), pictorial blood loss assessment chart (PBAC) score, and the size of the uterus and the lesion as measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, adverse events, assessment by the Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels, and anti-Muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, and 36 months after conservative surgery. Discussion The result of this large, multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation. Trial registration Chinese Clinical Trial Registry: ChiCTR1800014340 . Registered on 6 January 2018.