Hysteroscopic morcellation vs. curettage for removal of retained products of conception: a multicenter randomized controlled trial

医学 真空抽吸 宫腔镜检查 随机对照试验 外科 概念产品 刮除术 怀孕 流产 计划生育 研究方法 人口 遗传学 生物 环境卫生
作者
Liselot P. Wagenaar,Tjalina Hamerlynck,Celine M. Radder,Louisette W. Peters,Steven Weyers,B.C. Schoot,Huib AAM Van Vliet
出处
期刊:Fertility and Sterility [Elsevier]
卷期号:120 (6): 1243-1251 被引量:8
标识
DOI:10.1016/j.fertnstert.2023.08.956
摘要

To study the comparison between hysteroscopic morcellation (HM) of retained products of conception (RPOC) with ultrasound (US)-guided electric vacuum aspiration in terms of intrauterine adhesion (IUA) formation, efficacy, and complications.A randomized controlled, nonblinded trial.Three teaching hospitals and one university hospital from April 2015 to June 2022.A total of 133 women with RPOC on US, ranging from 1-4 cm, were randomized to receive either HM or electric vacuum aspiration.Hysteroscopic morcellation was performed with the TruClear System (Medtronic, Minneapolis, MN, USA). Electric vacuum aspiration was performed using an 8- or 10-mm flexible plastic Karman cannula under US guidance. Women allocated to vacuum aspiration underwent the procedure as soon as possible.In the HM group, an office diagnostic hysteroscopy was planned a minimum of 6 weeks after the end of pregnancy, followed by retained product of conception removal at least 8 weeks after the end of the pregnancy. Postoperatively, an office second-look hysteroscopy was scheduled to assess the primary outcome of IUAs.Postoperative IUAs were seen in 14.3% (9/63) of patients in the HM group and 20.6% (13/64) of patients in the vacuum aspiration group (-6% [-19.1% to 7.1%]). Significantly more RPOC were removed completely by HM compared with vacuum aspiration (95.2% vs. 82.5% (-14% [-24.9% to -3.1%]), and additional operative hysteroscopy was less frequently necessary in the HM group (12.5%) compared with the vacuum aspiration group (31.3%) (-20.1% [-34.3% to -6%]). The median operating time was shorter for vacuum aspiration compared with HM (5.80 minutes vs. 7.15 minutes). No differences were observed between HM and vacuum aspiration for the occurrence of intraoperative or postoperative complications (5.5% vs. 5.0% and 2.7% vs. 1.3%, respectively).In our randomized controlled trial, no significant differences were found in the occurrence of IUAs and complications. However, the RPOC were more often completely removed by HM than vacuum aspiration, and the HM group required fewer additional hysteroscopic treatments.NTR4923 (https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4923). Date of registration: November 23, 2014, date of initial participant enrollment: January 1, 2015.
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