Laparoscopic fundoplication is the treatment of choice for gastro-oesophageal reflux disease

Although the technical principles of surgical repair remain the same in laparoscopic practice as in the classical open procedure, the increasing enthusiasm of patients and many physicians for this so-called “mini invasive” surgery has led to its greater use and wider indications for surgery in gastro-oesophageal reflux disease (GORD). The notion behind this proposed change in current practice is that antireflux surgery (ARS) is more “cost effective” than medical therapy and possibly safer with regard to the long term effects of acid suppression and occurrence of adenocarcinoma of the oesophagus in patients with severe chronic GORD. Our position challenges this view, which in our opinion is not supported by scientific evidence and data in the recent literature. If it is assumed that modern drug therapy and ARS are both effective in the treatment of GORD, a comparison between them should concentrate on several end points that have been recognised as major goals of antireflux therapy. Hence in addition to healing of oesophagitis, emphasis now needs to be given to complete symptom relief, return to a normal quality of life, and long term control of the disease (that is, prevention of recurrences and complications). Tolerance, safety, and costs are also important issues.

EFFICACY OF ARS VERSUS MEDICAL THERAPY

Comparison is limited by lack of randomised trials between laparoscopic surgery and modern drug therapy (that is, proton pump inhibitors (PPIs)). Although Spechler¹ first reported that open ARS was significantly better than medical therapy after two or three years of follow up, the comparison involved drugs which are no longer considered as optimal therapy for GORD. Interestingly, the same author recently reassessed the long term outcome of these cohorts of medically and surgically treated patients after a median follow up of approximately 10 years.² Oesophagitis grade, quality of life scores, satisfaction with antireflux therapy, and frequency of GORD related complications did not differ significantly between the two groups. Recently, Lundell et al compared the results of open ARS and omeprazole after three³ and five years⁴ of follow up in a large multicentre prospective randomised study. Results were similar when patients in the omeprazole group were allowed to adjust for the PPI dose according to individual needs. There was no evidence of any general superiority of open ARS over long term drug treatment and there was no reason to suspect that the laparoscopic approach may be more effective than the open one. Indeed, even after successful laparoscopic ARS, quality of life does not return to normal.⁵ Finally, oesophageal dysmotility, if initially present, is not corrected by ARS but may eventually complicate it.⁶

However, one could argue that the superiority of ARS may be limited to a selected part of the GORD spectrum. In fact, there are no convincing data for the efficacy of ARS in treating patients with oesophagitis refractory to PPIs. With optimised dose and dosing frequency regimens, even severe oesophagitis is healed in more than 90% of cases after eight weeks, and this healing rate may increase with continuation of therapy. Therefore, PPI refractoriness is a rare indication for ARS. On the contrary, the more generally accepted view is that the best indication for surgery is a patient who actually responds to PPI but wishes to discontinue the medication. However, recent data do not confirm this notion because the majority of patients (62%) continued to take antireflux medications regularly after surgery.² The reason for this continued intake of drugs after ARS is not completely clear. Deterioration of results reported 10–20 years after surgery is usually due to disruption of the fundic wrap⁷ although drug consumption may not necessarily reflect therapeutic failure.

Recent studies, especially those performed in a primary care setting, have shown that up to 70% of patients with frequent heartburn do not have mucosal breaks at endoscopy (non-erosive reflux disease (NERD)).⁸ While randomised studies have now demonstrated the efficacy of PPIs on symptoms, quality of life, and maintenance in remission, there are no controlled or even large prospective studies of ARS in these NERD patients. Data from PPI trials indicate that these patients do not have a mild disease but frequently respond less well to acid suppression.⁹ For some, the role of other pathogenic factors, such as enhanced sensitivity and/or permeability of the oesophageal mucosa, may be of crucial importance. The frequent association of dyspepsia and GORD symptoms in these patients⁵ may also be detrimental to ARS results. Therefore, extreme caution must be exercised before extending indications for laparoscopic surgery to this group of patients.

Are GORD complications such as strictures or bleeding ulcers an indication for ARS? Although it is difficult to answer this question due to a lack of comparative studies (and the difficulty of conducting them), it is apparent that most of these complications occur in elderly patients who are poor candidates for surgery because of their general status or associated illnesses. In contrast, when strictures are present and symptomatic, maintenance therapy with a PPI regimen has been shown to be very effective after initial endoscopic dilatation.

Extraoesophageal manifestations of GORD, such as asthma, chronic cough, non-cardiac chest pain, and ear, nose, and throat symptoms, represent a difficult situation from both diagnostic and therapeutic standpoints. Several uncontrolled observations have suggested that open or laparoscopic ARS may reduce or even abolish atypical symptoms.^10,11 However, the same magnitude of improvement has been reported with omeprazole.¹² For example, a recent uncontrolled trial evaluating titrated omeprazole treatment found that 73% of non-allergic asthmatics with symptomatic GORD and abnormal acid exposure had a clinical response.¹³ Finally, two placebo controlled trials showed that omeprazole was effective in patients with non-cardiac chest pain^14,15 whereas only uncontrolled observations had suggested the efficacy of ARS.¹⁶ On the whole, the efficacy of both medical and surgical treatments in patients with extraoesophageal manifestations seems less impressive than in those with typical symptoms.

In summary, the available literature does not allow clear identification of a subset of patients for whom ARS may be more effective than PPI therapy. Moreover, the results of surgery are more difficult to evaluate due to the heterogeneity of techniques, the level of experience of surgeons, and the fact that evaluation criteria and study designs were less rigorously defined in surgical studies than in trials involving PPIs.

SIDE EFFECTS AND LONG TERM SAFETY OF ARS VERSUS MEDICAL THERAPY

GORD is not usually a life threatening condition.¹⁰ Although there are now convincing data for the safety and tolerance of PPI strategies over a 10 year period,^17,18 this is not the case for ARS. Postoperative mortality for ARS ranges from 0.1% to 0.8% in cohort studies and may even be slightly higher in less experienced centres. Postoperative morbidity is also quite prevalent, with the frequency of persisting dysphagia ranging between 1% and 8%. Laparoscopic ARS cannot be considered safer than open ARS as a recent randomised study¹⁹ concluded that this approach is more frequently complicated by persistent postoperative dysphagia than open fundoplication. The learning curve to achieve a sufficient level of expertise in laparoscopic ARS is an important limitation, as the rate of complications continues to decline even after 100 procedures.²⁰ The fact that morbidity after ARS is frequently underestimated may largely account for the poorer outcome after laparoscopic fundoplication in community practice than in controlled studies, as illustrated by a recent report showing only 57% complete satisfaction after surgery in a US population.²¹ Finally, when all safety issues are considered, the balance is clearly in favour of medical treatment. This advantage could become even greater in the future if intermittent or on-demand PPI strategies are more frequently applied to patients with NERD.

RISK OF MALIGNANCIES DURING LONG TERM TREATMENT OF GORD

The fear of patients and physicians concerning cancer development in relation to GORD itself (risk of oesophageal adenocarcinoma) or GORD therapy (risk of gastric carcinoma) is difficult to evaluate retrospectively but has probably influenced the choice between PPIs and ARS in many instances. Some experimental data, such as better control of oesophageal biliary reflux with surgery than with PPI, are favourable to ARS, although their clinical relevance is far from being fully established. The situation is also difficult because of the complexity of the relationships between GORD and Helicobacter pylori infection.²² Although there is strong epidemiological evidence of an increased risk of adenocarcinoma of the oesophagus in patients with chronic heartburn, no definite proof exists indicating that ARS is more effective than medical therapy in preventing this rare complication.² On the other hand, the potential risk of gastric carcinoma is more linked to Helicobacter pylori infection than to PPI therapy although these drugs may slightly increase the risk of corpus gastric atrophy. In summary, the risk of cancer during long term GORD management seems to be very low and should not influence the choice between drug therapy and ARS.

MEDICOECONOMIC ASPECTS

One argument frequently advanced in favour of ARS in young healthy patients is the reduction in therapeutic cost compared with a lifetime schedule of PPI therapy.²³ Although it is difficult to extrapolate to lifetime expectancy, mathematical models as well as randomised studies do not support this assumption. For instance, Heudebert and colleagues²⁴ found that laparoscopic ARS in severe oesophagitis may only become more cost effective than PPIs after 10 years. Moreover, the model used was extremely sensitive to the cost of complications after surgery and may even have overestimated the cost of PPIs, given the increased prescription of generic drugs. Finally, the recent results of a large prospective randomised trial of open ARS versus omeprazole conducted in Scandinavia²⁵ indicated that drug therapy is less expensive than surgery, although cost variations in different countries are likely to be substantial, depending on healthcare systems.

CONCLUSION

Although ARS is an effective approach for long term control of GORD, its superiority over modern medical therapy is not established. Conversely, PPI therapy is efficient, safe, and cost effective in the long term (that is, at least 10 years). In view of the rapid improvement in our understanding of the pathogenesis of GORD and the potential for the development of new drugs to supplement our current medical armamentarium, it seems wise to limit indications for ARS to the following conditions: (a) refractoriness (or intolerance) to PPIs after optimising dose and dosing frequency, (b) unwillingness to continue drug therapy in a young patient fully informed about the hazards and complications of surgery, and (c) need for frequent dilatations despite adequate PPI therapy in a patient with a narrow oesophageal stricture. In patients with atypical manifestations, ARS should not be proposed before the contribution of GORD to symptoms has been established and a full trial of optimised PPI has failed. The debate is now further complicated by the rapid development of endoscopic therapy of GORD²⁶ which may represent another non-surgical option in the future.

Key points.

• Laparoscopic antireflux surgery is not more cost effective than PPI therapy in the long term (that is, at least 10 years).

• Postoperative morbidity after laparoscopic fundoplication is important.

• Results of laparoscopic antireflux surgery are highly surgeon dependent and probably less satisfactory in community practice than in expert centres.

• There is no evidence that laparoscopic fundoplication prevents oesophageal adenocarcinoma in GORD.