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Surgical treatment of gastro-oesophageal reflux disease (GORD) has previously been limited to chronic complicated reflux in patients with very longstanding severe symptoms. There is now an increasing tendency in many countries to utilise surgery in the earlier stages of the disease.1 This change in clinical practice is partly due to advances in surgical technique (laparoscopic approach) but paradoxically is also probably due to improvement in medical therapy.2,3 With the efficacy and availability of modern medical therapy, the focus, as well as the opportunities of therapy in GORD, have changed but also the recognition of the magnitude of the impairment in quality of life of GORD patients who are not adequately treated.4 This increased awareness may be the most pregnant cause of the suggested increase in prevalence of the disease in the adult population.
An important background factor for the significant but not eminent strategic decisions to be taken in the long term management of GORD patients is the fact that there are shortcomings and drawbacks with pharmacological maintenance therapy. GORD is a disease of a chronic nature where medical therapies are entirely targeting the control of acid reflux and not correcting the underlying motor abnormalities of the upper alimentary canal.5 Low dose proton pump inhibitor (PPI) therapy and full dose H2 receptor antagonists insufficiently interfere with food stimulated acid production and the latter also have a significant tachyphylaxis problem.6–8 A profound and sometimes prolonged acid rebound phenomenon is perhaps a greater problem after PPI therapy in Helicobacter pylori negative subjects than previously recognised. Furthermore, in patients with severe reflux disease, twice daily dosing of PPI is often necessary. In addition, there is sometimes insufficient control of volume reflux, nocturnal symptoms, and retrosternal pain. Acid breakthrough during the night has recently been recognised and a novel more complicated medical strategy has subsequently been designed.9 Another aspect causing some concern is worsening of the inflammation of the gastric mucosa in the corpus area and in Helicobacter pylori infected subjects. This topic has been vigorously debated recently.10,11 An additional issue of potential concern is the controversy prevailing regarding the significance of the non-acid reflux components (bile and pancreatic juice constituents) and their probable effects on the occurrence of columnar metaplasia12 as well as their impact on the perpetuation of the metaplastic-dysplastic processes leading to the rapidly increasing incidence of adenocarcinoma of the oesophagus.13,14 These many concerns already have an important impact on the attitudes towards complete control of reflux and will continue to do so in the future. Taken together, there seems to be a growing demand for complete and durable control of reflux based on the principle of reconstruction of the physiology of the gastro-oesophageal junction, which seems to be a reachable goal when a proper antireflux operation is performed.
A number of patient groups can be identified who are particularly suited to a laparoscopic antireflux operation. This decision is based mostly on the patient’s own preferences after a comprehensive and prolonged discussion with an experienced surgeon. The first group is those with chronic uncomplicated reflux disease which partly or totally responds to modern PPI therapy and requires continued medication to control the disease. Antireflux operations were previously indicated in cases where medical treatment could not prevent the disease from having a significant negative impact on the patient’s quality of life. This indication is still valid but modern therapy is so effective that only a minority of patients do not obtain substantial or complete relief of their symptoms. The problem of rapid and consistent relapse on cessation of therapy has been referred to, but perhaps more importantly is that many patients with chronic reflux do not want to be reliant on a form of medication that is yet to establish its safety over many years of continuous use (>10 years). Hence an important question we should ask is, are patients who do not respond adequately to PPI therapy suitable candidates for antireflux surgery? In a recent randomised clinical trial comparing open antireflux surgery with omeprazole, approximately 10% of patients were not initially controlled on 40 mg omeprazole daily.15 These patients were then, according to the protocol, offered antireflux surgery and did very well compared with the main group of patients randomised to respective therapies. The important message therefore must be that remaining symptoms of reflux and only a partial response to PPI therapy should not be considered unfavourable factors for the subsequent postoperative course after antireflux surgery.
COMPLICATED REFLUX DISEASE
Secondly, there is a group of patients with complicated reflux disease, represented by peptic strictures, the treatment of which has been greatly improved by the introduction of PPI.16 However, dilatable strictures in a young healthy patient is still an indication for fundoplication and dilatation. Furthermore, gastro-oesophageal regurgitation associated with aspiration of gastric juice into the pharynx and into the respiratory tree can cause laryngitis, recurrent pneumonia, bronchitis, and asthma. Respiratory complications due to reflux are firmly established indications for antireflux surgery although scientific evidence for the true benefit of antireflux surgery in an unselected group of reflux patients with alleged respiratory complications has still to be found.17–19 Indicated in the complicated reflux disease group is Barrett’s oesophagus (columnar lined oesophagus (CLO)). There is no consensus as to whether CLO remains an absolute indication for antireflux surgery. Evidence suggests that continued reflux may be deleterious for the dysplastic process in the oesophageal mucosa and in fact the results of a randomised trial presented some years ago suggested that antireflux surgery had advantages over medical therapy.20 However, a comprehensive comparison between antireflux surgery and modern updated PPI therapy has not been carried out in CLO patients. Recent circumstantial information would indicate that antireflux surgery has the potential to reverse metaplastic lesions in the cardiac region of reflux patients but continued follow up and more extensive clinical research are needed to allow firm conclusions on this delicate issue.21,22 At present, it can be concluded that antireflux surgery should aim for reflux and symptom control in patients with Barrett’s oesophagus rather than primarily to prevent progression of CLO and/or induce regression. In this context however it is interesting to note that adenocarcinoma of the oesophagus has been observed only rarely ≥5 years after a functioning antireflux procedure23 in CLO patients. In addition, recent clinical research has found that antireflux operations prevent the occurrence of intestinal metaplasia in columnar lined oesophagi.24
RECONSTRUCTION OF THE PHYSIOLOGY OF THE GASTRO-OESOPHAGEAL JUNCTION BY OPERATION
It is likely that all fundoplications being either total, partial anterior or posterior work in a similar way. This may be by both mechanical and physiological processes as these wraps are effective not only when placed in the chest in vivo but also when tested in animal viscera ex vivo.25 The principles of fundoplication operations are to mobilise the lower part of the oesophagus and to wrap the fundus of the stomach either partially or totally around the oesophagus. When the oesophageal hiatus is enlarged, it is narrowed by sutures to prevent para-oesophageal herniation and also to prevent the wrap from being pulled up into the chest. Antireflux procedures focus on three main components. Firstly, there is the anatomical repositioning of the lower oesophageal sphincter into the abdominal positive pressure environment with reduction of the hiatal hernia sack by dissection, mobilisation, and positioning of the crural sutures. This anatomical restoration per se may also have the potential to prevent reflux by reducing the hiatal hernia and by improving oesophageal clearance and crural function.26 Secondly, it has been suggested that peristaltic amplitude and other oesophageal body motor functions may improve after antireflux operations. However, it is not known if these observations can be explained by secondary compensatory mechanisms operational due to a subclinical outflow obstruction in the gastro-oesophageal junction caused, for example, by total fundoplication.27 Thirdly, the resting pressure of the lower oesophageal sphincter (LOS) and lengthening of the abdominal portion of the high pressure zone are important consequences of these operations. By continuously assessing LOS tone over a longer period of time, it has been shown that the pressure was considerably higher after total than after a partial posterior fundoplication.28 It should be noted that in the latter group the pressure level of the LOS region was very close to that seen in normal healthy controls. It should also be considered that total fundoplication may even over correct the mechanical deficiencies in the gastro-oesophageal junction with the risk of eliciting a super competent cardia. After a successful antireflux operation, LOS pressure never reaches a level at which free reflux is considered to occur.29–31 Furthermore, the number of transient LOS relaxations and the proportion of those associated with reflux are substantially reduced by an antireflux operation. After these operations, gas insufflation into the stomach or meal ingestion seldom elicit transient LOS relaxations which contrasts with the situation in unoperated GORD patients when these stimuli may trigger repeated relaxation of the LOS accompanied by reflux.28,32 Venting of air from the stomach may be a problem after some antireflux operations but it is easier after partial fundoplication than a total fundic wrap, as indicated by the occurrence of common cavities during manometry after gas insufflation into the stomach.
To complete the picture of restorative functions, it should be noted that delayed gastric emptying may be a contributory pathogenetic factor in up to 40% of GORD cases.33,34 Postfundoplication studies have consistently demonstrated accelerated gastric emptying after these operations. This is probably caused by a high gastric tone postprandially in the postoperative situation which accelerates the transfer of chyme to the distal part of the stomach thus facilitating emptying.35,36
Taken together, I conclude that antireflux procedures seem to significantly interfere with, and at least partly correct, important pathogenetic deficiencies in chronic GORD patients.
HOW TO REDUCE THE POTENTIAL DISADVANTAGES WITH ANTIREFLUX PROCEDURES?
There is a definite learning curve for surgeons in performing a laparoscopic fundoplication which strongly endorses the idea of centralising these procedures to high volume high quality centres and also the supervision of the surgical practice by an experienced surgeon.37 These specialised centres, with particular interest and understanding of the disease processes, also have the available technology to assess patients both before and eventually after their antireflux procedure.38,39 It is particularly important to offer similar services when problems or failures emerge.
The most frequent postfundoplication symptoms are dysphagia, inability to belch-vomit, postprandial fullness, bloating and pain, and socially embarrassing rectal flatus. The frequency with which these postfundoplication symptoms have been reported varies considerably between series.40,41 Dysphagia is frequently reported during the early postoperative period but seems to diminish with the passage of time, as may other postfundoplication symptoms. A recent randomised clinical trial suggest that laparoscopic total fundoplications are associated with more obstructive complaints in the early postoperative period than open procedures.42 Other similar trials have not been able to confirm these potential hazards of laparoscopic operations.43–45 However, as effective treatment for established severe postfundoplication symptoms is lacking, prevention is mandatory. There is a widespread consensus among experienced surgeons that if a complete wrap is performed it has to be both floppy and short. A large randomised trial has reported that posterior partial fundoplication is associated with less troublesome complaints of gas bloat-rectal flatus.46 Furthermore, laparoscopic anterior partial fundoplication has recently been reported to have similar advantages.47
Failure of fundoplication to control reflux occurs in a minority of patients. There are reports of a considerably high failure rate and it is important to emphasise that essentially all failures occur early in the postoperative period, indicating the importance of adhering to technical details and expertise.48–52 There are no data available to suggest that the failure rate is higher after laparoscopic fundoplication than traditionally seen after open operations.53 Success rates after redo surgery for failed primary operations are generally lower than after index operations. This should be taken into consideration, together with the fact that postoperative morbidity and mortality is many times higher. These data provide a strong case for referring these patients to specialised tertiary referral centres for assessment and careful investigations but also to ensure adequate surgical expertise to minimise the risk and optimise subsequent functional outcome.
THE US VETERAN MESSAGE
Unfortunately, very few randomised controlled clinical trials have been carried out comparing antireflux surgery with modern medical therapy. So far only one study has performed a head-to-head comparison between omeprazole and antireflux surgery in 310 oesophagitis patients54 in which a slight advantage of the operative treatment was observed after a minimum follow up period of five years. In the USA, a similar trial was initiated many years ago in severe reflux patients recruited from VA hospitals at a time when medical therapy was quite different from the present level of efficacy. The two year follow up data showed effects strongly in favour of surgical therapy.55 Using a unique methodology, 38 of the initial 82 operated patients were traced 10 years after operation and the results of this long term follow up have recently been published.56 There are a number of very important issues raised by this study. One is the high frequency of antisecretory drugs taken by operated patients, allegedly to control recurrent reflux symptoms. In this context it is important to realise that it is not sufficient to just record the fact that patients may take antisecretory therapy after similar operations as the reasons vary considerably, as we found in our randomised controlled clinical trial54 and others have found when patients have been followed up many years after laparoscopic fundoplication.57
Secondly, Spechler and colleagues56 found that operated patients had a survival curve that was significantly inferior to that of medically treated patients. This enhanced mortality after an antireflux operation was mainly due to cardiovascular events but did not stop the authors from drawing conclusions on the attitude towards the indication for antireflux surgery. In our Nordic GORD trial,54 after a minimum of seven years of follow up, no survival difference between operated and non-operated patients was found.
Thirdly, there was no significant difference in the number of adenocarcinomas when the two study groups were compared (one in the antireflux surgery group and four in the medically treated group). The number of events was to small to allow meaningful comparisons but what is important is to assess the function of the antireflux procedure in patients who develop adenocarcinoma after antireflux surgery (see above).
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