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 [post]

2020 unpublished
To preserve fertility or integrity of organs was on the rise for the most women with adenomyosis. Adenomyomectomy is now a widely applied conservative surgery, however relapse is a serious problem after operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the recurrence rate in patients. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy of GnRHa for decreasing the
more » ... ecreasing 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 accessed with Visual Analogue Scale (VRS) and Numeric Rating Scale (NRS), Pictorial blood loss assessment chart (PBAC) score and the size of uterus and lesion are 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, and adverse events, assessing by 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, 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. Recently AI Jama retrospectively analyzed 18 patients, accepting adenomyomectomy and GnRHa for 24 weeks, 15 of which had systematic improvement after one year's follow-up [16] . Liu carried out an uncontrolled descriptive study of 186 women with pathologically proven adenomyoma, who underwent ultramini-laparoscopic adenomyomectomy and a 6-month course of goserelin acetate treatment. After 3 years' follow-up, the rate of systematic recurrence was 9% [19] . Wang et al.' prospective non-randomized study found a significant decline of relapse rate in surgical-medical treatment group at the end of 2-year follow-up [7] . However, our retrospective result showed no difference between control and intervention group at the end of first or second year. It is noteworthy that there was a significant difference between control and GnRH agonist group with symptomatic or imaging relapse at the end of 36 months' follow-up. In other words, postoperative treatment might be
doi:10.21203/rs.2.12204/v4 fatcat:g6aj742ldbcm5o65q64lsnguzi