这项研究的目的是确定疗效,安全,与有症状的子宫平滑肌瘤(ULs)患者相比,腹腔镜射频消融(LAP-RFA)与子宫肌瘤切除术的医疗保健资源使用。
这是对原始上市后随机数据的二次分析,多中心,纵向,比较TRUST(保留子宫技术的治疗结果)在有症状的ULs患者中进行的美国试验。手术后,受试者随访12个月.
多中心试验,包括有或没有学术关系的医院,手术中心,和生育中心为子宫肌瘤进行门诊手术。
共有57例患者随机接受LAP-RFA(n=30)或子宫肌瘤切除术(n=27)。
LAP-RFA或子宫肌瘤切除术(腹腔镜或腹部)。
本研究的主要结局指标是原始TRUST试验的次要结局的一部分。这项研究的主要结果是随着时间的推移,UL症状的减少和患者报告的结果评分的改善。次要结果包括术后住院,逗留时间,并发症,再干预,和恢复时间。在手术后3个月和12个月,每个治疗组的UL症状均有显着改善。这些改善在治疗组之间相似.LAP-RFA和子宫肌瘤切除术后,基线和12个月之间的UL症状显着减少72%和85%,分别。随着时间的推移,两组患者报告的所有结局评分均有显着改善。手术后3个月和12个月,LAP-RFA组住院患者的百分比分别比腹腔镜子宫肌瘤剔除术组低74%和49%,分别,3个月的差异有统计学意义。与子宫肌瘤切除术组相比,LAP-RFA组的住院时间明显缩短(8.0±5.7小时vs18.8±14.6小时;p<0.05)。与子宫肌瘤切除术组相比,LAP-RFA组患者在恢复工作前的休假时间明显减少(10.3±5.1天vs14.5±5.4天;p<0.05)。与子宫肌瘤切除术组相比,LAP-RFA组恢复正常活动的总天数显着降低(16.3±15.2天vs26.5±15.9天;p<0.05)。
这项为期12个月的随访研究结果表明,LAP-RFA是一种安全的,有效,保留子宫替代腹腔镜子宫肌瘤切除术治疗ULs。这些数据点建立在先前发表的研究基础上,这些研究表明LAP-RFA整体医疗资源使用较低。包括较低的术后住院率和较短的住院时间。在临床实践中,LAP-RFA是一种有希望的治疗妇女ULs的方法。
The objective of this study was to determine the efficacy, safety, and healthcare resource use of laparoscopic radiofrequency ablation (LAP-RFA) compared with myomectomy in patients with symptomatic uterine leiomyomas (ULs).
This was a secondary analysis of the original postmarket randomized, multicenter, longitudinal, comparative TRUST (Treatment Results of Uterine Sparing Technologies) United States trial in patients with symptomatic ULs. After the procedure, subjects were followed over a 12-month period.
Multicenter trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine myomas.
A total of 57 patients were randomized to either LAP-RFA (n = 30) or myomectomy (n = 27).
LAP-RFA or myomectomy (laparoscopic or abdominal).
The main outcome measures of this study were part of the secondary outcomes of the original TRUST trial. The primary outcome of this study was the reduction of UL symptoms and the improvement in patient-reported outcomes scores over time. Secondary outcomes included postprocedure hospitalization, length of stay, complications, reinterventions, and recovery time. There was a significant improvement in UL symptoms at 3 and 12 months after the procedure within each treatment group, and these improvements were similar between treatment groups. There was a significant reduction in UL symptoms per month between baseline and 12-months after the procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively. A significant improvement was seen in all patient-reported outcomes scores over time for both groups. At 3 and 12 months after the procedure, the percentages of patients who were hospitalized in the LAP-RFA group were 74% and 49% lower than those of patients in the laparoscopic myomectomy group, respectively, with the 3-month difference being statistically significant. The length of hospital stay was significantly shorter in the LAP-RFA group compared with the myomectomy group (8.0 ± 5.7 hours vs 18.8 ± 14.6 hours; p < .05). Doctors recommended taking significantly less time off before returning to work for the patients in the LAP-RFA group compared with those in the myomectomy group (10.3 ± 5.1 days vs 14.5 ± 5.4 days; p < .05). The total number of days until back to normal activity was significantly lower in the LAP-RFA group compared with the myomectomy group (16.3 ± 15.2 days vs 26.5 ± 15.9 days; p < .05).
The results from this 12-month follow-up study suggest that LAP-RFA is a safe, effective, uterine-sparing alternative to laparoscopic myomectomy in the treatment of ULs. These data points build on previously published studies showing that LAP-RFA has lower healthcare resource use overall, including lower postprocedure hospitalization rate and shorter length of stay. In clinical practice, LAP-RFA is a promising treatment approach to ULs for women.