One-step conservative surgery vs hysterectomy for placenta accreta spectrum: a feasibility randomized controlled trial

Abstract

BackgroundPlacenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is one-step conservative surgery, which involves the en-bloc resection of the myometrium affected by placenta accreta spectrum alongwith the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the two tecchniques in the setting of randomized controlled trial. ObjectiveWe performed a prospectively registered multi-center randomized controlled trial comparing hysterectomy with one-step conservative suergery. The aim was to collect feasibility and clinical outcomes of the two techniques in women assigned to hysterectomy or one-step conservative repair. Apart from participant acceptability for randomization, we also collected intraoperative blood loss, transfusion requirement, serious adverse event and other clinical outcomes. Study DesignSixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly either to hysterectomy (n=31) or one-step conservative surgery (n=29). ResultsDuring a 20-month period, 60 of the 64 eligible patients (93.7%) underwent randomization. Intention to treat analysis showed that the clinical outcomes for one-step conservative surgery were comparable to those for hystectomy. Median intraoperative bleed loss (1740 mL (IQR 1010 - 2410) vs 1500 mL (IQR 1122 - 2753), OR 1 (1-1, p=0.942)), median duration of surgery (IQR 135 minutes (111-180) vs 155 minutes (IQR 120-185), OR 0.99 (0.98-1, p=0.151)), transfusion rates (58.6% vs 61.3%. OR 0.96 (0.83-1.76, p=0.768)), and adverse events (17.2% vs 9.7%, OR 1.77 (0.43-10.19, p=0.398) respectively). Comparison of sub-group of women with type 1 class on topographic classification showed that one-step surgery was successful in all participants allocated to that group and the clinical outcomes were superior to hysterectomy with a shorter surgery duration (median 125 (IQR 98-128) vs 180 (129-226) minutes, p=0.002), lower transfusion rates (46.2% vs 82.4%), and fewer units of red blood cells transfused (median 1 (IQR 1-1.8) vs 3 (IQR 2-4) units, p=0.007) respectively. ConclusionA randomized controlled trial comparing two surgical techniques for the treatment of placenta accreta spectrum is feasible. One-step conservative repair is a valid alternative to hysterctomy in the large majority, but this can only be ascertained following intra-operative surgical staging. Trial registration numberNCT05013749