Why does NICE not recommend laparoscopic herniorraphy?

NICE's reluctance to recommend laparoscopic repair of hernias is based mainly on economic considerations, some of which are inaccurate, according to Roger Motson

More than 100 000 inguinal herniorraphies are carried out each year in the United Kingdom, making it one of the commonest operations. Newer techniques have superseded the simple suture technique popularised by Bassini more than 100 years ago: firstly the tension-free darn with monofilament nylon and then the Lichtenstein repair with a polypropylene mesh patch.¹,² Although there was no initial randomised trial of the Lichtenstein technique, it rapidly gained popularity during the past decade. Laparoscopic repair, which places a considerably larger polypropylene mesh patch against the inner surface of the abdominal wall than that used in the Lichtenstein technique, was first performed about 10 years ago.³,⁴ This larger patch reinforces the entire groin, covering the sites of both indirect and direct inguinal hernias and also of femoral hernias. The position of the mesh is the same as that used in the open Stoppa repair,⁵ but the laparoscopic approach has the great advantage of avoiding the large incision required for this technique.

Summary points

• Inguinal herniorraphy is one of the commonest operations in the United Kingdom

• Laparoscopic herniorraphy is less painful postoperatively than traditional open repair and allows the patient to return to work more quickly

• The true costs of laparoscopic repair are lower than those of open repair, particularly when it allows detection and simultaneous repair of an undiagnosed contralateral hernia

• Surgeons are under-represented on NICE's appraisal panel

Laparoscopic repair has been subject to a number of randomised trials, recently summarised by the European Hernia Trials Group, who found that the incidences of recurrence in laparoscopic and Lichtenstein repairs were similar (2.3% and 2.9%, respectively).⁶ The only differences in clinical outcomes were a reduction in postoperative pain and an earlier return to work for patients after a laparoscopic repair. With laparascopic repair, undiagnosed hernias in the other groin can be identified and repaired at the same time as the index hernia at minimal additional cost in up to 15% of patients.⁷,⁸

With this improvement in outcome and additional diagnostic yield of contralateral hernias NICE might have been expected to have recommended the laparoscopic operation for the repair of primary inguinal hernias, or at least have regarded it as equal to the Lichtenstein repair. NICE, however, has stated that open mesh (that is, Lichtenstein) repair should be the “preferred” procedure for repair of primary inguinal hernias and that laparoscopic repair should be “considered” only for recurrent or bilateral hernias (box).⁹

NICE guidance on hernia repair

For repair of primary inguinal hernia, open (mesh) should be the preferred surgical procedure

For repair of recurrent and bilateral inguinal hernia, laparoscopic repair should be considered

When laparoscopic surgery is undertaken for inguinal hernia, the totally extraperitoneal (TEP) procedure should be preferred

Laparoscopic surgery for inguinal hernia should be undertaken only in those units with appropriately trained operating teams which regularly undertake these procedures

Preferred and considered by whom?—the 23 members of the NICE appraisal panel include pharmacologists, healthcare economists, patient representatives, and one surgeon. Apart from written submissions, principally by the Association of Endoscopic Surgeons of Great Britain and Ireland, oral evidence was taken from just one surgical expert. Patients do not seem to prefer open repair: a survey from the Royal Surrey County Hospital, Guildford, of patients who had experienced both open and laparoscopic repairs found that 9 out of 10 preferred the laparoscopic approach (M E Bailey, personal communication, 2001).

Is NICE correct in its cost calculations?

NICE has made it clear that the reasons for its choice have more to do with control of NHS costs than with clinical excellence. It calculated that the cost of an open repair was £412, whereas that of a laparoscopic repair was estimated to be £747. These calculations can be challenged on several grounds. Firstly, out of hospital costs were not included, so substantial reductions in social security and employers' costs after laparoscopic repair were ignored. Cost savings from reduced time off work have been estimated as £160-£400 in one study¹⁰ and up to £800 in another trial.¹¹ Secondly, NICE erroneously assumed that the laparoscopic equipment (telescope, camera, light source, television monitor, etc) would be used only for hernia repair. In practice, of course, the equipment is also used for other laparoscopic procedures, particularly cholecystectomy.

Although NICE showed that laparoscopic repair for recurrent or bilateral hernias offered clear cost savings over open repair, and better outcomes, it recommended that the procedure need only be “considered.” Also, NICE does not seem to have taken into account the potential for additional cost savings from intraoperative identification of occult contralateral hernias during laparoscopic repairs. About 25% of patients will need a second operation to repair a hernia in the contralateral groin. Many of these hernias would be identifiable at the time of the initial repair and could be treated with little additional cost.

Telling patients the options

Four situations are possible: a patient with a primary hernia may see either a surgeon untrained or a surgeon trained in laparoscopic repair, and so may a patient with recurrent or bilateral hernias. In the first case surgeons would explain to the patient the details of an open mesh repair; for the patient to be able to give informed consent, they would also need to tell the patient that there is another method of repair that they themselves do not perform. Presumably they would need to say that the results of laparoscopic repair (“keyhole surgery”) are similar to those of open operation with regard to recurrence and adverse events but that the procedure costs more and hurts less. If return to full activity was an issue, as it is for many patients, then they would have to tell the patient that return to work is likely to be slower after open repair, but that a government agency and they themselves prefer this method. Patients then nevertheless opting for laparoscopic repair would presumably be referred to a suitable colleague.

If the same patient with a primary hernia was seen by a laparoscopic surgeon the advice would be a little different. Laparoscopic surgeons would explain to the patient the details of both laparoscopic and open mesh repair and provide the same information with regard to recurrence and adverse events. They might also add that a government agency prefers the open method, largely because it is cheaper. They would support the recommendation for keyhole surgery on the basis of reduced discomfort at the time of surgery, early return to full activity, and lower incidence of wound infection or chronic groin pain. They would further explain that if the patient was unfit for general surgery then they would be limited to open operation under general anaesthetic. Most laparoscopic surgeons would perform the open operation themselves if that was the patient's preference, but in my own and other laparoscopic surgeons' experience the majority of patients opt for laparoscopic repair.

In the situation where a patient with recurrent or bilateral hernias is seen by a non-laparoscopic surgeon the consent process would need to explain that there are advantages to a laparoscopic approach. As NICE requires laparoscopic repair only to be “considered”, the surgeon would not seem to be under any obligation to refer the patient to a laparoscopically trained colleague unless the patient requests it. Where a patient with recurrent or bilateral hernias sees a laparoscopic surgeon, clearly the benefits of laparoscopic repair in these more complex situations are so apparent that it would be difficult for a laparoscopic surgeon to recommend anything else unless, again, the patient was unfit for a general anaesthetic.

NICE has also expressed a preference for one of the two laparoscopic techniques available, the totally extraperitoneal (TEP) rather than the transabdominal preperitoneal (TAPP) method, even though there is no statistically significant difference in outcome between the two techniques. Some early complications were reported with the transabdominal method, which was the first widely used laparoscopic repair, but these problems have been surmounted and are not described in more recent reports.

It is of interest that the NICE appraisal panel (members of which, with one exception, are not surgeons and who have not performed or seen either procedure) decided to advise on which technique surgeons should use for laparoscopic repair. By contrast, although NICE advised on the type of prosthesis to be used for hip replacement surgery it did not tell orthopaedic surgeons that the prosthesis should be inserted by only one of the surgical approaches to the hip joint.

Conclusion

As with other types of laparoscopic surgery, proper training is essential to achieve good results. I hope that surgeons who are adequately trained will not encounter resistance from their chief executives when they want to introduce (or continue using) laparoscopic techniques. I have no doubt that units with a surgeon (or surgeons) trained in laparoscopic hernia repair will continue to flourish as increasingly well informed patients seek out hospitals in which their hernias can be repaired with little pain and early return to full activity. After all, there are few takers for open cholecystectomy any more.