Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial
| Autor: | Peter M. van de Ven, Judith A.F. Huirne, Jonas van de Lande, Andreas L. Thurkow, Inge de Milliano, Huib A.A.M. van Vliet, Marlies Y. Bongers, Celine Radder, Wouter J. K. Hehenkamp |
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| Přispěvatelé: | Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), Epidemiology and Data Science, APH - Methodology, APH - Quality of Care, APH - Societal Participation & Health, ACS - Heart failure & arrhythmias, ACS - Atherosclerosis & ischemic syndromes, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, Graduate School, Obstetrics and Gynaecology, ARD - Amsterdam Reproduction and Development, APH - Aging & Later Life |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Norpregnadienes
medicine.medical_treatment surgical ease Blood Loss Surgical MULTICENTER Laparoscopic myomectomy Gonadotropin-releasing hormone Carcinoma Ovarian Epithelial law.invention Gonadotropin-Releasing Hormone chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Laparotomy Ulipristal acetate ulipristal acetate laparoscopic myomectomy 030212 general & internal medicine Original Research Article gonadotropin-releasing hormone agonist Netherlands Ovarian Neoplasms 030219 obstetrics & reproductive medicine Leiomyoma Publications Obstetrics and Gynecology WOMEN General Medicine pretreatment intraoperative blood loss Contraceptive Agents Hormonal Uterine Neoplasms Female Intramuscular injection Adult medicine.medical_specialty medicine.drug_class Operative Time Urology Placebo Hysterectomy 03 medical and health sciences Double-Blind Method Gonadotropin-releasing hormone agonist Uterine Myomectomy medicine Humans gonadotropin‐releasing hormone agonist Sutures business.industry chemistry Gynecology Laparoscopy business Hormone |
| Zdroj: | Acta Obstetricia et Gynecologica Scandinavica, 99(1), 89-98. Wiley-Blackwell Acta Obstetricia et Gynecologica Scandinavica, 74(12), 711-712. Wiley-Blackwell Acta Obstetricia et Gynecologica Scandinavica Acta Obstetricia et Gynecologica Scandinavica, 99(1), 89-98. Wiley De Milliano, I, Huirne, J A F, Thurkow, A L, Radder, C, Bongers, M Y, Van Vliet, H, Van De Lande, J, Van De Ven, P M & 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, vol. 74, no. 12, pp. 711-712 . https://doi.org/10.1097/01.ogx.0000615324.55914.5c de Milliano, I, Huirne, J A F, Thurkow, A L, Radder, C, Bongers, M Y, van Vliet, H, van de Lande, J, van de Ven, P M & Hehenkamp, W J K 2020, ' 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, vol. 99, no. 1, pp. 89-98 . https://doi.org/10.1111/aogs.13713 Acta obstetricia et gynecologica Scandinavica, 99(1), 89-98. Wiley-Blackwell Obstetrical & gynecological survey, 74(12), 711-712. Lippincott Williams and Wilkins |
| ISSN: | 0001-6349 0029-7828 |
| DOI: | 10.1097/01.ogx.0000615324.55914.5c |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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