■为了描述两年的术后结果,3种保留子宫的干预措施用于治疗女性壁内和/或浆膜下子宫肌瘤。
■这是一个后市场,随机化,prospective,多中心,纵向,介入,和比较临床研究,以评估LAP-RFA与标准子宫保存技术(子宫肌瘤切除术和UAE)治疗有症状的子宫肌瘤的成本和健康结局。对于这项RCT研究,54名受试者在三个程序中以1:1的比例随机分配,并随访两年。他们的结果与2017-2020年IBMMarketScan®商业数据库的回顾性美国保险索赔进行了比较,其中96,854名女性接受了子宫保留手术治疗。
■LAP-RFA的平均门诊手术中心费用和平均门诊住院费用最低($13,134和$14,428),阿联酋最高($28,214和$19,131)。任何后续手术的两年总再干预率(AM,LM,LAP-RFA,或阿联酋)在AM组最低(0%),其次是LM(4.2%),LAP-RFA(11%),阿联酋(33%)。LAP-RFA的围手术期平均再干预成本和平均再干预总成本分别为2429美元和5939美元,LM为2122美元和8368美元,上午4410美元和11,942美元,阿联酋科目8113美元和46,692美元。在RCT研究中,LAP-RFA组患者的平均住院时间(8.2小时)明显少于腹腔镜子宫肌瘤剔除术组患者(16.0小时)和开腹子宫肌瘤剔除术组患者(33.6小时).尽管数量少,两年的再干预率遵循与IBMMarketScan数据类似的模式。
■在比较这三种非侵入性方法时,LAP-RFA与最低的围手术期费用相关,阿联酋与最高的围手术期费用相关。需要进一步的研究来评估成本,有效性,以及受试者对每个程序的满意度。
UNASSIGNED: To describe two-year post-operative outcomes, and healthcare utilization of three uterus-sparing interventions used to treat women with intramural and/or subserosal uterine fibroids.
UNASSIGNED: This was a post-market, randomized, prospective, multi-center, longitudinal, interventional, and comparative clinical study to evaluate the costs and health outcomes of LAP-RFA vs the standard uterine conserving technologies (myomectomy and UAE) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation. For this RCT study, 54 subjects were randomized on a 1:1 ratio across the three procedures and followed out to two years. Their results were compared to retrospective US insurance claims from the IBM MarketScan® Commercial Database from 2017-2020 for 96,854 women who underwent a uterus-sparing procedure for fibroids.
UNASSIGNED: Mean ambulatory surgical center costs and the mean out-patient hospital costs were lowest for LAP-RFA ($13,134 and $14,428) and highest for UAE ($28,214 and $19,131). The total two-year re-intervention rate of any subsequent procedure (AM, LM, LAP-RFA, or UAE) was lowest in AM group (0%) followed by LM (4.2%), LAP-RFA (11%), and UAE (33%). Mean peri-operative reintervention costs and the mean reintervention total costs were $2429 and $5939 for LAP-RFA, $2122 and $8368 for LM, $4410 and $11,942 for AM, and $8113 and $46,692 for UAE subjects. In the RCT study, the average length of hospital stay was significantly less for the LAP-RFA group subjects (8.2 hours) in contrast to both the laparoscopic myomectomy group subjects (16.0 hours) and the abdominal myomectomy group subjects (33.6 hours). Despite the small numbers, two-year reintervention rates followed a similar pattern as the IBM MarketScan data.
UNASSIGNED: In comparing these three non-invasive approaches, LAP-RFA was associated with the lowest peri-operative cost, and UAE was associated with the highest peri-operative cost. Further studies are needed to assess the cost, effectiveness, and subject satisfaction with each procedure.