McCormack K, Wake B, Perez J, Fraser C, Cook J, McIntosh E, Vale L, Grant A
Health Services Research Unit, Institute of Applied Health Sciences, University of Aberdeen, UK.
Health Technol Assess. 2005 Apr;9(14):1-203, iii-iv. doi: 10.3310/hta9140.
To determine whether laparoscopic methods are more effective and cost-effective than open mesh methods of inguinal hernia repair, and then whether laparoscopic transabdominal preperitoneal (TAPP) repair is more effective and cost-effective than laparoscopic totally extraperitoneal (TEP).
Electronic databases. Conference proceedings. Manufacturers' submissions to the National Institute for Clinical Excellence (NICE) were reviewed.
Selected studies were rigorously assessed. Dichotomous outcome data were combined using the relative risk method and continuous outcomes were combined using the Mantel-Haenszel weighted mean difference method. Time to return to usual activities was described using hazard ratios derived from individual patient data reanalysis. A review of economic evaluations undertaken by NICE in 2001 was updated and an economic evaluation was performed. The estimation of cost-effectiveness focused on the comparison of laparoscopic repair with open flat mesh. A Markov model incorporating the data from the systematic review was used to estimate cost-effectiveness for a time horizon up to 25 years.
Thirty-seven randomised control trials (RCTs) and quasi-RCTs met the inclusion criteria on effectiveness. Fourteen studies were included in the review of economic evaluations. Laparoscopic repair was associated with a faster return to usual activities and less persisting pain and numbness. There also appeared to be fewer cases of wound/superficial infection and haematoma. However, operation times are longer and there appears to be a higher rate of serious complications in respect of visceral (especially bladder) injuries. Mesh infection is very uncommon with similar rates noted between the surgical approaches. There is no apparent difference in the rate of hernia recurrence. Laparoscopic repair was more costly to the health service than open repair, with an estimated extra cost from studies conducted in the UK of about 300-350 pounds per patient. The point estimates of cost provided by the economic model also suggest that the laparoscopic techniques are more costly (approximately 100-200 pounds more per patient after 5 years). From the review of economic evaluations, the estimates of incremental cost per additional day at usual activities were between 86 pounds and 130 pounds. Where productivity costs were included, they eliminated the cost differential between laparoscopic and open repair. Additional analysis incorporating new trial evidence suggested that TEP was associated with significantly more recurrences than open mesh but these data did not greatly influence cost-effectiveness.
For the management of unilateral hernias, the base-case analysis and most of the sensitivity analysis suggest that open flat mesh is the least costly option but provides less quality adjusted life years (QALYs) than TEP or TAPP. TEP is likely to dominate TAPP (on average TEP is estimated to be less costly and more effective). It is likely that, for management of symptomatic bilateral hernias, laparoscopic repair would be more cost-effective as differences in operation time (a key cost driver) may be reduced and differences in convalescence time are more marked (hence QALYs will increase) for laparoscopic compared with open mesh repair. When possible repair of contralateral occult hernias is taken into account, TEP repair is most likely to be considered cost-effective at threshold values for the cost per additional QALY above 20,000 pounds. The increased adoption of laparoscopic techniques may allow patients to return to usual activities faster. This may, for some people, reduce any loss of income. For the NHS, increased use of laparoscopic repair would lead to an increased requirement for training and the risk of serious complications may be higher. Chronic pain should now be addressed prospectively using standard definitions and allowing assessment of the degree of pain. More evidence is required on the loss of utility caused by persisting pain and numbness, as well as serious complications resulting from minor surgery. Prospective population-based registries of new surgical procedures may be the best way to address this, as a complement to randomised trials assessing effectiveness. Further research relating to whether the balance of advantages and disadvantages changes when hernias are recurrent or bilateral is also required as current data are limited. Methodologically sound RCTs are needed to consider the relative merits and risks of TAPP and TEP. Further methodological research is required into the complexity of laparoscopic groin hernia repair and the improvement of performance that accompanies experience.
确定腹腔镜手术方法在腹股沟疝修补术中是否比开放补片修补术更有效且更具成本效益,以及腹腔镜经腹腹膜前修补术(TAPP)是否比腹腔镜完全腹膜外修补术(TEP)更有效且更具成本效益。
电子数据库。会议论文集。审查了制造商提交给国家临床优化研究所(NICE)的材料。
对选定的研究进行严格评估。二分法结局数据采用相对危险度法合并,连续结局采用Mantel-Haenszel加权均数差法合并。通过对个体患者数据重新分析得出的风险比来描述恢复正常活动的时间。更新了NICE在2001年进行的经济评估综述,并进行了一项经济评估。成本效益评估主要集中在腹腔镜修补术与开放平片修补术的比较上。使用一个纳入系统评价数据的马尔可夫模型来估计长达25年时间范围内的成本效益。
37项随机对照试验(RCT)和准RCT符合有效性纳入标准。14项研究被纳入经济评估综述。腹腔镜修补术与更快恢复正常活动、持续疼痛和麻木较少相关。伤口/浅表感染和血肿病例似乎也较少。然而,手术时间较长,内脏(尤其是膀胱)损伤导致的严重并发症发生率似乎较高。补片感染非常罕见,两种手术方法的发生率相似。疝复发率没有明显差异。与开放修补术相比,腹腔镜修补术对医疗服务的成本更高,英国研究估计每位患者额外成本约为300 - 350英镑。经济模型提供的成本点估计也表明,腹腔镜技术成本更高(5年后每位患者大约多100 - 200英镑)。从经济评估综述来看,每增加一天正常活动的增量成本估计在86英镑至130英镑之间。纳入生产力成本后,消除了腹腔镜修补术和开放修补术之间的成本差异。纳入新试验证据的额外分析表明,TEP的复发率明显高于开放补片,但这些数据对成本效益影响不大。
对于单侧疝的治疗,基础病例分析和大多数敏感性分析表明,开放平片是成本最低的选择,但与TEP或TAPP相比,其质量调整生命年(QALY)较少。TEP可能优于TAPP(平均估计TEP成本更低且更有效)。对于有症状的双侧疝治疗,腹腔镜修补术可能更具成本效益,因为手术时间(一个关键成本驱动因素)的差异可能会减小,与开放补片修补术相比,腹腔镜修补术的康复时间差异更明显(因此QALY会增加)。当考虑对侧隐匿疝的可能修补时,对于每增加一个QALY成本阈值高于20000英镑的情况,TEP修补术最有可能被认为具有成本效益。腹腔镜技术应用的增加可能使患者更快恢复正常活动。对一些人来说这可能会减少收入损失。对于英国国家医疗服务体系(NHS)而言,腹腔镜修补术使用的增加将导致培训需求增加,严重并发症的风险可能更高。现在应该使用标准定义前瞻性地处理慢性疼痛,并允许对疼痛程度进行评估。需要更多关于持续疼痛和麻木导致的效用损失以及小手术引起的严重并发症的证据。新手术的前瞻性人群登记可能是解决这个问题的最佳方法,作为评估有效性的随机试验的补充。还需要进一步研究疝复发或双侧疝时利弊平衡是否会改变,因为目前数据有限。需要方法学完善的RCT来考虑TAPP和TEP的相对优缺点和风险。需要对腹腔镜腹股沟疝修补术的复杂性以及经验积累带来的性能改善进行进一步的方法学研究。