肥胖患者子宫内膜癌的机器人辅助子宫切除术:健康技术评估。

Q1 Medicine Ontario Health Technology Assessment Series Pub Date : 2023-10-10 eCollection Date: 2023-01-01
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引用次数: 0

摘要

背景:机器人辅助手术已经在安大略省的医院使用了十多年,但是没有公共资金用于机器人系统或进行机器人辅助手术所需的一次性用品(“一次性机器人”)。我们对机器人辅助子宫切除术(RH)治疗肥胖患者子宫内膜癌进行了健康技术评估。我们的评估包括对生殖健康的有效性、安全性和成本效益的评估,以及安大略省卫生部公共资助生殖健康的5年预算影响。它还研究了患有子宫内膜癌和肥胖的人的经历、偏好和价值观,以及那些为子宫内膜癌提供手术治疗的医疗保健专业人员。方法:我们对临床证据进行了系统的文献检索,以确定与我们的研究问题相关的系统评价和随机对照试验。我们从纳入的系统评价中报告了偏倚风险。我们根据建议分级评估、发展和评价(GRADE)工作组标准评估了证据体的质量。我们进行了系统的经济文献检索。我们还分析了安大略省子宫内膜癌和肥胖症患者5年公共资助RH(包括全部、部分和彻底手术)的预算影响。为了了解RH对子宫内膜癌和肥胖患者的潜在价值,我们采访了有过子宫内膜癌和肥胖经历的人,他们接受了微创手术(腹腔镜子宫切除术[LH]或RH),我们还采访了实施子宫切除术的妇科癌症外科医生。结果:我们在临床证据综述中纳入了一篇系统综述。一项间接比较显示,在体重指数(BMI)≥30 kg/m2的患者中,LH和RH到开放式子宫切除术(OH)的转换率相似(分别为6.5%和5.5%)(评分:非常低)。在一组身体质量指数(BMI)≥40 kg/m2的患者中进行的间接比较显示,与RH患者相比,LH患者需要转化为OH的比例更高(分别为7.0%和3.8%)(GRADE:非常低)。LH和RH的围手术期并发症发生率同样较低(≤3.5%)(评分:非常低)。我们确定了两项符合经济文献综述纳入标准的研究。纳入的经济学研究发现,RH治疗子宫内膜癌的成本高于OH或LH;然而,由于这些研究是在其他国家进行的,因此结果不适用于安大略省的情况。假设机器人辅助手术的数量适度增加,我们的参考案例分析表明,为子宫内膜癌和肥胖症患者提供公共资助的RH的5年预算影响将为114万美元。预算影响分析结果对手术量和一次性机器人成本敏感。我们采访的那些有过子宫内膜癌和肥胖经历的人,以及妇科癌症外科医生,都对RH及其对患有子宫内膜癌和肥胖的人的好处表示赞赏,认为它比OH和LH更有好处。结论:与LH相比,RH与子宫内膜癌和肥胖患者(即BMI≥40 kg/m2的患者)较少转化为OH相关。LH和RH的围手术期并发症发生率同样较低。对于患有子宫内膜癌和肥胖的人,RH的成本效益尚不清楚。我们估计,为患有子宫内膜癌和肥胖症的人提供公共资助的RH的5年预算影响将达到114万美元。我们采访过的患有子宫内膜癌和肥胖的人都对微创子宫切除术(LH或RH)的经历表示赞同,并强调了为肥胖患者提供安全手术选择的重要性。妇科外科医生认为,对于患有子宫内膜癌和肥胖的人来说,RH是OH和LH的更好选择。
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Robotic-Assisted Hysterectomy for Endometrial Cancer in People With Obesity: A Health Technology Assessment.

Background: Robotic-assisted surgery has been used in Ontario hospitals for over a decade, but there is no public funding for the robotic systems or the disposables required to perform robotic-assisted surgeries ("robotics disposables"). We conducted a health technology assessment of robotic-assisted hysterectomy (RH) for the treatment of endometrial cancer in people with obesity. Our assessment included an evaluation of the effectiveness, safety, and cost-effectiveness of RH, as well as the 5-year budget impact for the Ontario Ministry of Health of publicly funding RH. It also looked at the experiences, preferences, and values of people with endometrial cancer and obesity, as well as those of health care professionals who provide surgical treatment for endometrial cancer.

Methods: We performed a systematic literature search of the clinical evidence to identify systematic reviews and randomized controlled trials relevant to our research question. We reported the risk of bias from the included systematic review. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We also analyzed the 5-year budget impact of publicly funding RH (including total, partial, and radical procedures) for people with endometrial cancer and obesity in Ontario. To contextualize the potential value of RH for people with endometrial cancer and obesity, we spoke with people with lived experience of endometrial cancer and obesity who had undergone minimally invasive surgery (either laparoscopic hysterectomy [LH] or RH), and we spoke with gynecological cancer surgeons who perform hysterectomy.

Results: We included one systematic review in the clinical evidence review. An indirect comparison showed that conversion rates to open hysterectomy (OH) were similar for LH and RH in patients with a body mass index (BMI) ≥ 30 kg/m2 (6.5% vs. 5.5%, respectively) (GRADE: Very low). An indirect comparison within a subset of patients with a body mass index (BMI) ≥ 40 kg/m2 showed that a higher proportion of patients who underwent LH required conversion to OH compared with patients who underwent RH (7.0% vs. 3.8%, respectively) (GRADE: Very low). Rates of perioperative complications were similarly low for both LH and RH (≤ 3.5%) (GRADE: Very low). We identified two studies that met the inclusion criteria of our economic literature review. The included economic studies found RH to be more costly than OH or LH for endometrial cancer; however, because these studies were conducted in other countries, the results were not applicable to the Ontario context. Assuming a moderate increase in the volume of robotic-assisted surgeries, our reference case analysis showed that the 5-year budget impact of publicly funding RH for people with endometrial cancer and obesity would be $1.14 million. The budget impact analysis results were sensitive to surgical volume and the cost of robotics disposables. The people we spoke with who had lived experience of endometrial cancer and obesity, as well as gynecological cancer surgeons, spoke favourably of RH and its perceived benefits over OH and LH for people with endometrial cancer and obesity.

Conclusions: Compared with LH, RH is associated with fewer conversions to OH in patients with endometrial cancer and obesity (i.e., those with a BMI ≥ 40 kg/m2). Rates of perioperative complications were similarly low for both LH and RH. The cost-effectiveness of RH for people with endometrial cancer and obesity is unknown. We estimate that the 5-year budget impact of publicly funding RH for people with endometrial cancer and obesity would be $1.14 million. People we spoke with who had lived experience of endometrial cancer and obesity reported favourably on their experiences with minimally invasive hysterectomy (either LH or RH) and emphasized the importance of the availability of safe surgical options for people with obesity. Gynecological surgeons perceived RH as a superior alternative to OH and LH for people with endometrial cancer and obesity.

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Ontario Health Technology Assessment Series
Ontario Health Technology Assessment Series Medicine-Medicine (miscellaneous)
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