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01-12-2020 | Triptorelin | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2020

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.

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Title: 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
Authors: 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
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Triptorelin
Estradiol
GnRH Agonists
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04294-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Method/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Method/design

Discussion

Trial registration

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