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机器人辅助腹腔镜子宫切除术治疗子宫内膜癌女性患者——并发症、女性患者体验、生活质量及卫生经济学评估

Robotic-assisted laparoscopic hysterectomy for women with endometrial cancer - complications, women´s experiences, quality of life and a health economic evaluation.

作者信息

Herling Suzanne Forsyth

出版信息

Dan Med J. 2016 Jul;63(7).

Abstract

This thesis contains four studies all focusing on women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy (RALH). Women with endometrial cancer are typically elderly with co-morbidities. RALH is a relatively new treatment option which has been introduced and adopted over the last decade without randomised controlled trials (RCTs) to prove superiority over other surgical alternatives. The purpose of the thesis was to explore and describe patient and health economic outcomes of RALH for women with endometrial cancer using different research approaches. The first study was a retrospective descriptive cohort study with 235 women. The aim was to explore types and incidence of post-operative complications within 12 months after RALH reported with the Clavien-Dindo scale. We found that 6% had severe complications and that women with lymphadenectomy did not have an increased rate of complications. Urinary tract and port site infections were the most frequent complications. The second study was a qualitative interview study where we explored the experience of undergoing RALH. Using content analysis, we analysed semi-structured interviews with 12 women who had undergone RALH on average 12 weeks earlier. The women were positive towards the robotic approach and felt recovered shortly after. They expressed uncertainty with the normal course of bleeding and bowel movement post-operatively as well as with the new anatomy. The third study was an economic evaluation; an activity-based costing study including 360 women comparing total abdominal hysterectomy (TAH) to RALH. This study showed that for women with endometrial cancer, RALH was cheaper compared to TAH, mainly due to fewer complications and shorter length of stay (LOS) that counterbalanced the higher robotic expenses. When including all cost drivers the analysis showed that the RALH procedure was more than 9.000 Danish kroner (DKK) cheaper than the TAH. Increased age and Type 2 diabetes appeared to increase costs. The fourth study was a prospective cohort study of 139 women who were followed four months after surgery with the aim to assess short term changes in health-related quality of life (HRQoL), symptoms and function after RALH. Both a general and an illness specific HRQoL questionnaire were used. The preoperative baseline measurement was compared with measurements at one and five weeks and four months post-operatively. The women also selfreported their level of activity once a week for the first five weeks after surgery. We found that HRQoL was back to baseline level at five weeks post-operatively for the majority of women. Fatigue, constipation, gastrointestinal symptoms, pain, appetite and change of taste were negatively affected short-term. At five weeks the mean level of physical activity resumed was 84%. Together, the studies indicate that RALH is a well-tolerated surgical treatment for women with endometrial cancer, and post-operative complications appear fewer and less severe compared to previous open surgery. This points towards RALH being clinically and economically efficient. The women experienced that RALH was easy to overcome and they felt recovered shortly after. However, they expressed uncertainty about the normal post-operative cause and reported changes in functions and symptoms short term after surgery. These changes should be addressed in the preoperative information and at the post-operative follow-up. It is difficult imagining a RCT of robotic-assisted laparoscopic hysterectomy being conducted in the future due to reluctance towards randomisation to open surgery. However, it would be advisable continuously to monitor relevant surgical and patient-reported outcomes as indications for robotic surgery may alter, experiences may develop and further technical advances may change robotic surgery for women with endometrial cancer in the future.

摘要

本论文包含四项研究,均聚焦于接受机器人辅助腹腔镜子宫切除术(RALH)的子宫内膜癌女性患者。子宫内膜癌女性患者通常年事已高且伴有多种合并症。RALH是一种相对较新的治疗选择,在过去十年中已被引入并采用,但尚无随机对照试验(RCT)来证明其优于其他手术方式。本论文的目的是使用不同的研究方法,探索并描述RALH治疗子宫内膜癌女性患者的患者和健康经济结果。第一项研究是一项回顾性描述性队列研究,涉及235名女性。目的是探讨采用Clavien-Dindo分级报告的RALH术后12个月内的并发症类型及发生率。我们发现6%的患者出现严重并发症,且接受淋巴结清扫术的女性并发症发生率并未增加。泌尿系统和切口部位感染是最常见的并发症。第二项研究是一项定性访谈研究,我们探讨了接受RALH的经历。通过内容分析,我们分析了对12名平均在12周前接受RALH的女性进行的半结构化访谈。这些女性对机器人手术方式持积极态度,且术后不久就感觉恢复良好。她们对术后正常的出血和排便过程以及新的解剖结构表示不确定。第三项研究是一项经济评估;一项基于活动成本核算的研究,纳入360名女性,比较全腹子宫切除术(TAH)和RALH。该研究表明,对于子宫内膜癌女性患者,RALH比TAH成本更低,主要是因为并发症更少且住院时间更短,这抵消了机器人手术费用较高的问题。当纳入所有成本驱动因素时,分析表明RALH手术比TAH便宜超过9000丹麦克朗(DKK)。年龄增加和2型糖尿病似乎会增加成本。第四项研究是一项对139名女性的前瞻性队列研究,在术后四个月对她们进行随访,目的是评估RALH术后健康相关生活质量(HRQoL)、症状和功能的短期变化。使用了一份通用的和一份疾病特异性的HRQoL问卷。将术前基线测量结果与术后1周、5周和4个月的测量结果进行比较。这些女性还在术后的前五个星期每周自行报告一次她们的活动水平。我们发现,大多数女性在术后5周时HRQoL恢复到基线水平。疲劳、便秘、胃肠道症状、疼痛、食欲和味觉变化在短期内受到负面影响。在5周时,身体活动恢复的平均水平为84%。总体而言,这些研究表明,RALH是一种子宫内膜癌女性患者耐受性良好的手术治疗方式,与以往的开放手术相比,术后并发症似乎更少且更不严重。这表明RALH在临床和经济方面是有效的。这些女性体验到RALH很容易克服,且术后不久就感觉恢复良好。然而,她们对术后的正常情况表示不确定,并报告了术后短期内功能和症状方面的变化。这些变化应在术前告知和术后随访中加以解决。由于人们不愿意随机接受开放手术,很难想象未来会进行机器人辅助腹腔镜子宫切除术的RCT。然而,鉴于机器人手术的适应证可能会改变、经验可能会发展以及未来技术的进一步进步可能会改变子宫内膜癌女性患者的机器人手术方式,持续监测相关的手术和患者报告结果是可取的。

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