TY - JOUR
T1 - One-step conservative surgery vs hysterectomy for placenta accreta spectrum
T2 - a feasibility randomized controlled trial
AU - Nieto-Calvache, Álbaro José
AU - Aryananda, Rozi Aditya
AU - Palacios-Jaraquemada, José Miguel
AU - Cininta, Nareswari
AU - Grace, Ariani
AU - Benavides-Calvache, Juan Pablo
AU - Campos, Clara Ivette
AU - Messa-Bryon, Adriana
AU - Vallecilla, Liliana
AU - Sarria, Daniela
AU - Galindo, Juan Sebastian
AU - Galindo-Velasco, Valentina
AU - Rivera-Torres, Luisa Fernanda
AU - Burgos-Luna, Juan Manuel
AU - Bhide, Amarnath
N1 - Publisher Copyright:
© 2024 Elsevier Inc.
PY - 2024/6
Y1 - 2024/6
N2 - BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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). RESULTS: 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). CONCLUSION: 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.
AB - BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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). RESULTS: 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). CONCLUSION: 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.
KW - accreta
KW - randomized controlled trial
KW - surgical technique
KW - uterine sparing surgery
UR - http://www.scopus.com/inward/record.url?scp=85188711240&partnerID=8YFLogxK
U2 - 10.1016/j.ajogmf.2024.101333
DO - 10.1016/j.ajogmf.2024.101333
M3 - Article
C2 - 38458362
AN - SCOPUS:85188711240
SN - 2589-9333
VL - 6
JO - American Journal of Obstetrics and Gynecology MFM
JF - American Journal of Obstetrics and Gynecology MFM
IS - 6
M1 - 101333
ER -