Department of OB/GYN, David Geffen School of Medicine, University of California - Los Angeles, Los Angeles, CA.
Texas Fertility Center, Austin, TX.
JSLS. 2020 Oct-Dec;24(4). doi: 10.4293/JSLS.2020.00050.
Postoperative safety outcomes with laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation, as performed by gynecologic surgeons new to the procedure, were evaluated and compared to the premarket, pivotal study. Post-procedure feedback from surgeons was reported.
This was a post-market, prospective, single-arm analysis with 4 to 8 weeks follow-up among surgeons (n = 29) with varying levels of laparoscopic surgery experience participating in the ongoing, multinational Treatment Results of Uterine Sparing Technologies randomized clinical trial. Patients were premenopausal adult women (n = 110) desiring uterine-conserving treatment for symptomatic fibroids. During run-in, surgeons received proctored training. Following training, and after performing ≥ 2 procedures, surgeons provided self-assessment and feedback using a standardized form.
Surgeons performed 105 procedures with 100 per-protocol patients. The average number of proctored cases per surgeon was 2.48. No acute (≤ 48 hours) serious adverse events occurred (0/101, 0.0%) compared with 2 acute serious adverse events in the premarket study (2/137, 1.46%). Both studies reported 1 near-term (∼30 days) serious adverse event (< 1% for both). In this study, the near-term complication was fever of unknown origin requiring hospitalization related to uterine entry/manipulation. This was categorized as probably device-related; the patient was treated with antibiotics and discharged. Twenty-six surgeons completed the evaluation form; none reported experiencing problems with the procedure.
Minimally invasive gynecologic surgeons can learn laparoscopic intraabdominal ultrasound-guided radiofrequency ablation and perform it safely (in terms of acute and near-term serious adverse events) after ≥ 2 proctored cases. There were no significant differences in safety outcomes compared to the premarket, pivotal study.
评估并比较妇科新术者行腹腔镜下腹腔内超声引导射频消融术的术后安全性结果，该研究为上市后前瞻性单臂分析，随访时间为 4-8 周，共有不同腹腔镜手术经验的术者（n=29）参与正在进行的多国子宫保留技术治疗效果随机临床试验。研究纳入 110 例有症状子宫肌瘤且希望保留子宫的绝经前成年女性患者。入组前，术者接受有监督培训。培训后，术者在完成≥2 例手术后，使用标准化表格进行自我评估和反馈。
术者共完成 105 例手术，100 例符合方案患者。每位术者平均接受监督的病例数为 2.48 例。与上市前研究中 2 例（2/137，1.46%）急性（≤48 小时）严重不良事件相比，本研究中无 1 例（0/101，0.0%）发生急性严重不良事件。两项研究均报告 1 例近期（约 30 天）严重不良事件（两者均<1%）。本研究中，近期并发症为不明原因发热，需住院治疗与子宫进入/操作有关，可能与器械相关，患者接受抗生素治疗后出院。26 名术者完成了评估表，均表示未遇到手术相关问题。
微创妇科术者在接受 2 例监督病例后可以学习并安全地（就急性和近期严重不良事件而言）进行腹腔镜下腹腔内超声引导射频消融术，与上市前关键性研究相比，安全性结果无显著差异。
