Departamento de Ginecología y Obstetricia, Fundación Valle del Lili, Cali, Colombia (Drs Nieto-Calvache, Benavides-Calvache, Messa-Bryon, and Burgos-Luna).
Obstetrics & Gynecology department of Dr. Soetomo General Academic Teaching Hospital, Universitas Airlangga, Surabaya, Indonesia (Drs Aryananda and Cininta).
Am J Obstet Gynecol MFM. 2024 Jun;6(6):101333. doi: 10.1016/j.ajogmf.2024.101333. Epub 2024 Mar 6.
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.
胎盘植入谱系疾病是一种与严重产妇发病率甚至死亡率相关的严重疾病。推荐的治疗方法是子宫切除术。另一种选择是一步式保守手术，包括整块切除受胎盘植入谱系疾病影响的子宫肌层和胎盘，然后进行子宫重建。目前，尚无研究在随机对照试验中比较这两种技术。
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式保守手术。目的是收集在分配给子宫切除术或一步式保守手术的女性中这两种技术的可行性和临床结果。除了评估参与者被随机分配的意愿外，我们还收集了术中出血量、输血需求、严重不良事件和其他临床结果的数据。
60 名产前强烈怀疑胎盘植入谱系疾病的女性被随机分配至子宫切除术（n=31）或一步式保守手术（n=29）。
在 20 个月的时间内，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，一步式保守手术的临床结果与子宫切除术相当（术中出血量中位数，1740ml[四分位距，1010-2410]与 1500ml[四分位距，1122-2753]；比值比，1[1-1]；P=.942；手术时间中位数，135 分钟[四分位距，111-180]与 155 分钟[四分位距，120-185]；比值比，0.99[0.98-1]；P=.151；输血率，58.6%与 61.3%；比值比，0.96[0.83-1.76]；P=.768；不良事件发生率，17.2%与 9.7%；比值比，1.77[0.43-10.19]；P=.398]）。在拓扑分类为 1 型的女性亚组中，所有分配至一步式手术的参与者均取得成功结果，其优于子宫切除术。这表现在手术时间更短（中位数，125[四分位距，98-128]与 180[129-226]分钟；P=.002）、输血率更低（46.2%与 82.4%）以及输血量更少（中位数，1[四分位距，1-1.8]与 3[四分位距，2-4]单位；P=.007）。
比较胎盘植入谱系疾病两种手术治疗方法的随机对照试验是可行的。一步式保守修复在大多数情况下是子宫切除术的有效替代方法，但只有在术中进行手术分期后才能确定。
