Aim/Principal research question
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).
Factors of interest
Recurrence. Pain. Numbness. Quality of life (QoL). Costs. Operation time. Complications, Length of hospital stay. Return to usual activities.
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 on behalf of 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.
Patients with a clinical diagnosis of inguinal hernia for whom surgical management was judged appropriate. Where possible, analyses based on IPD from randomised patients were included in the meta-analysis, including data obtained for any patients excluded from the original published analyses. Where data allowed, the patient population was split according to whether or not the hernia was recurrent or bilateral and whether or not the patient was fit enough for general anaesthesia. Data from children aged 12 years and older were included where these patients were included in a trial of adults; however, trials specifically relating to children were not included. For the economic assessment, studies had to involve the comparison of alternative methods of hernia repair in terms of their costs and effectiveness.
Hernia recurrence. Persisting pain. 'Opposite' method initiated where a laparoscopic repair initiated when an open repair was allocated, or vice versa. Conversion where a procedure initiated as a laparoscopic was converted to an open repair, or vice versa. Duration of operation. Postoperative pain. Haematoma. Seroma. Wound/superficial infection. Mesh/deep infection. Port-site hernia. Vascular injury. Visceral injury. Length of hospital stay. Time to return to usual activities. Persisting numbness. QoL.
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 per patient. The point estimates of cost provided by the economic model also suggest that the laparoscopic techniques are more costly (approximately £100–200 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 and £130. Where productivity costs were included, they eliminated the cost differential between laparoscopic and open repair. It was highly likely that the incremental cost per QALY of laparoscopic repair compared with open mesh repair was less than £20,000. The results were most sensitive to assumption made about the utility associated with avoiding long terms pain and numbness. 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) although this conclusion is not based on directly comparative data and no meaningful difference between TAPP and TEP may exist. 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. The data available for this sub-group analysis limited and conclusions remain tentative. 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.
Implications for future research
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.
Project-related web site
Grant A (2005). Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. The Research Findings Register. Summary number 1441. Retrieved 18 May 2006, from http://www.ReFeR.nhs.uk/ViewRecord.asp?ID=1441