Department of Obstetrics and Gynecology, Catharina Hospital, Michelangelolaan 2, Eindhoven, The Netherlands.
Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Women's Clinic, Ghent University Hospital, Ghent, Belgium.
Fertil Steril. 2023 Dec;120(6):1243-1251. doi: 10.1016/j.fertnstert.2023.08.956. Epub 2023 Aug 30.
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.
研究宫腔镜下碎胎术（HM）与超声（US）引导下电动吸引术治疗妊娠物残留（RPOC）在宫腔粘连（IUA）形成、疗效和并发症方面的比较。
随机对照、非盲法试验。
三家教学医院和一家大学医院，时间从 2015 年 4 月至 2022 年 6 月。
共有 133 名经 US 检查发现 RPOC 的患者，范围为 1-4 cm，随机分为 HM 组或电动吸引组。
HM 组采用 TruClear 系统（美敦力，明尼苏达州明尼阿波利斯）进行宫腔镜下碎胎术。电动吸引组采用 8 或 10mm 弹性塑料 Karman 套管在 US 引导下进行。分配到吸引组的患者尽快进行手术。
在 HM 组中，妊娠结束后至少 6 周行门诊诊断性宫腔镜检查，然后至少在妊娠结束后 8 周行妊娠物残留清除术。术后行门诊二次宫腔镜检查，评估 IUA 的主要结局。
HM 组术后发生 IUA 者占 14.3%（9/63），电动吸引组占 20.6%（13/64）（-6%[-19.1%至 7.1%]）。与电动吸引组相比，HM 组完全清除 RPOC 的比例更高（95.2%比 82.5%[-14%[-24.9%至-3.1%]），且 HM 组需要进一步宫腔镜治疗的比例更低（12.5%比 31.3%[-20.1%[-34.3%至-6%]）。与 HM 组相比，电动吸引组的手术时间更短（5.80 分钟比 7.15 分钟）。HM 组和电动吸引组术中或术后并发症的发生率无差异（分别为 5.5%比 5.0%和 2.7%比 1.3%）。
在本随机对照试验中，HM 与电动吸引术治疗 RPOC 在 IUA 发生率和并发症方面无显著差异。然而，HM 组比电动吸引术更常能完全清除 RPOC，且 HM 组需要进一步宫腔镜治疗的比例更低。
NTR4923（https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4923）。登记日期：2014 年 11 月 23 日，首次入组日期：2015 年 1 月 1 日。
