背景:胎盘植入谱是一种严重的疾病,与显著的产妇发病率甚至死亡率相关。推荐的治疗方法是子宫切除术。另一种选择是一步保守手术,这包括整块切除受胎盘植入谱影响的子宫肌层,其次是子宫重建。目前,在随机对照试验的背景下,没有比较这两种技术的研究。
目的:我们进行了一项前瞻性注册的多中心随机对照试验,比较了子宫切除术和一步保守手术。目的是收集两种技术在子宫切除术或一步保守修复的女性中的可行性和临床结果。除了参与者对随机化的可接受性,我们还收集了术中失血量,输血要求,严重不良事件和其他临床结局。
方法:60名产前强烈怀疑胎盘植入的妇女被随机分配到子宫切除术(n=31)或一步保守手术(n=29)。
结果:在20个月期间,64名符合条件的患者中有60名(93.7%)接受了随机分组。意向治疗分析显示,一步保守性手术的临床结果与膀胱切除术相当。术中出血中位数(1740mL(IQR1010-2410)与1500mL(IQR1122-2753),OR1(1-1,p=0.942),中位手术时间(IQR135分钟(111-180)vs155分钟(IQR120-185),或0.99(0.98-1,p=0.151)),输血率(58.6%vs61.3%。OR0.96(0.83-1.76,p=0.768)),和不良事件(17.2%对9.7%,OR分别为1.77(0.43-10.19,p=0.398))。对1型女性的亚组进行地形图分类的比较表明,在分配到该组的所有参与者中,一步手术都是成功的,临床结果优于子宫切除术,手术时间较短(中位数125(IQR98-128)vs180(129-226)分钟,p=0.002),输血率较低(46.2%vs82.4%),和较少单位的红细胞输注(中位数1(IQR1-1.8)对3(IQR2-4)单位,p=0.007)。
结论:一项比较两种手术技术治疗胎盘植入谱的随机对照试验是可行的。在大多数情况下,一步保守修复是子宫切除术的有效替代方法,但这只能在术中手术分期后才能确定。
背景:NCT05013749。
Placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled
trial.
We performed a prospectively registered multicenter randomized controlled
trial comparing hysterectomy with 1-step conservative surgery. The aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1-step conservative surgery. In addition to assessing participants\' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes.
Sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29).
During a 20-month period, 60 of the 64 eligible patients (93.7%) underwent randomization. Intention-to-treat analysis showed that the clinical outcomes for 1-step conservative surgery were comparable to those of hysterectomy (median intraoperative blood loss, 1740 mL [interquartile range, 1010-2410] vs 1500 mL [interquartile range, 1122-2753]; odds ratio, 1 [1-1]; P=.942; median duration of surgery, 135 minutes [interquartile range, 111-180] vs 155 minutes [interquartile range, 120-185]; odds ratio, 0.99 [0.98-1]; P=.151; transfusion rate, 58.6% vs 61.3%; odds ratio, 0.96 [0.83-1.76]; P=.768; and adverse event rate, 17.2% vs 9.7%; odds ratio, 1.77 [0.43-10.19]; P=.398; respectively). In the subgroup of women with type 1 class on topographic classification, all participants allocated to 1-step surgery had successful outcomes, which were superior to those of hysterectomy. This was evidenced by the shorter surgery duration (median, 125 [interquartile range, 98-128] vs 180 [129-226] minutes; P=.002), lower transfusion rates (46.2% vs 82.4%), and fewer units of red blood cells transfused (median, 1 [interquartile range, 1-1.8] vs 3 [interquartile range, 2-4] units; P=.007).
A randomized controlled
trial comparing 2 surgical techniques for the treatment of placenta accreta spectrum is feasible. One-step conservative repair is a valid alternative to hysterectomy in the large majority of cases, but this can only be ascertained following intraoperative surgical staging. El resumen está disponible en Español al final del artículo.