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Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial.

Abstract

INTRODUCTION

Laparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra- and postoperative outcomes.

MATERIAL AND METHODS

We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease.

RESULTS

Thirty women received UPA and 25 women leuprolide acetate. Non-inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa.

CONCLUSIONS

Non-inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, University Medical Center Amterdam, location VU Medical Center, Amsterdam, The Netherlands.Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, University Medical Center Amterdam, location VU Medical Center, Amsterdam, The Netherlands.Department of Obstetrics and Gynecology, University Medical Center Amterdam, location Academic Medical Center, Amsterdam, The Netherlands.Department of Obstetrics and Gynecology, OLVG, Amsterdam, The Netherlands.Department of Obstetrics and Gynecology, Maxima Medical Center, Veldhoven, The Netherlands. Department of Obstetrics and Gynecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands.Department of Obstetrics and Gynecology, Catharina Hospital, Eindhoven, The Netherlands.Department of Obstetrics and Gynecology, Spaarne Gasthuis, Haarlem, The Netherlands.Department of Biostatistics, VU University, Amsterdam, The Netherlands.Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, University Medical Center Amterdam, location VU Medical Center, Amsterdam, The Netherlands.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31468503

Citation

de Milliano, Inge, et al. "Ulipristal Acetate Vs Gonadotropin-releasing Hormone Agonists Prior to Laparoscopic Myomectomy (MYOMEX Trial): Short-term Results of a Double-blind Randomized Controlled Trial." Acta Obstetricia Et Gynecologica Scandinavica, 2019.
de Milliano I, Huirne JAF, Thurkow AL, et al. Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial. Acta Obstet Gynecol Scand. 2019.
de Milliano, I., Huirne, J. A. F., Thurkow, A. L., Radder, C., Bongers, M. Y., van Vliet, H., ... Hehenkamp, W. J. K. (2019). Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial. Acta Obstetricia Et Gynecologica Scandinavica, doi:10.1111/aogs.13713.
de Milliano I, et al. Ulipristal Acetate Vs Gonadotropin-releasing Hormone Agonists Prior to Laparoscopic Myomectomy (MYOMEX Trial): Short-term Results of a Double-blind Randomized Controlled Trial. Acta Obstet Gynecol Scand. 2019 Aug 29; PubMed PMID: 31468503.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial. AU - de Milliano,Inge, AU - Huirne,Judith A F, AU - Thurkow,Andreas L, AU - Radder,Celine, AU - Bongers,Marlies Y, AU - van Vliet,Huib, AU - van de Lande,Jonas, AU - van de Ven,Peter M, AU - Hehenkamp,Wouter J K, Y1 - 2019/08/29/ PY - 2019/02/21/received PY - 2019/08/08/revised PY - 2019/08/18/accepted PY - 2019/8/31/pubmed PY - 2019/8/31/medline PY - 2019/8/31/entrez KW - gonadotropin-releasing hormone agonist KW - intraoperative blood loss KW - laparoscopic myomectomy KW - pretreatment KW - surgical ease KW - ulipristal acetate JF - Acta obstetricia et gynecologica Scandinavica JO - Acta Obstet Gynecol Scand N2 - INTRODUCTION: Laparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra- and postoperative outcomes. MATERIAL AND METHODS: We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease. RESULTS: Thirty women received UPA and 25 women leuprolide acetate. Non-inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa. CONCLUSIONS: Non-inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters. SN - 1600-0412 UR - https://www.unboundmedicine.com/medline/citation/31468503/Ulipristal_acetate_vs_gonadotropin-releasing_hormone_agonists_prior_to_laparoscopic_myomectomy_(MYOMEX_trial):_Short-term_results_of_a_double-blind_randomized_controlled_trial L2 - https://doi.org/10.1111/aogs.13713 DB - PRIME DP - Unbound Medicine ER -