Therapy of gastro-oesophageal reflux: An updated approach to anti reflux surgery
1 Department of Surgery, Karolinska University Hospital, Huddinge, Stockholm, Sweden
The authors aim is the answer to diferent questions: How effective is anti reflux surgery (ARS) compared to modern medical therapy in the long-term management of GORD, what is the evidence supporting one operative approach before another and If the ARS strategy is endorsed how this surgery should be done to maximise GORD control and minimise side effects.
Surgery should always be looked upon as complementary to medical therapy in the long-term management of patients with chronic GORD. GORD represents an increasing health problem among adults in the western world. Available medical therapies are effective and adequate for the control of disease manifestations in the great majority of GORD patients. For patients who have a suboptimal disease control under medical therapy and in those who for various reasons want to discuss an alternative to medical long-term therapy, the following message can be transmitted.Antireflux surgery is a well-documented effective long-term therapeutic alternative to control GORD. The outcome after surgery is dependent on the experience and quality of the surgeon. These operations are safe but mortality can never attain a zero level and the morbidity has to be realized. Antireflux surgery has to be centralized within each country.
With the aim of optimizing the outcome of anti-reflux surgery, the surgeon has to perform and master a delicate act of balance on the choice between various fundoplication procedures. On one hand we have the total fundoplication with its proved efficacy regarding reflux control but with it associated mechanical side-effects leading to symptoms relating to the relative obstruction in the gastrooesophageal junction and the inability to vent air from the stomach and the sequel that follow. The posterior partial fundoplication has obvious advantages with less postfundoplication complaints without compromising the level of reflux control and can therefore often be recommended. Some studies present very promising results following anterior partial fundoplications but confirmative studies are warranted. The spectrum of postfundoplication symptoms can be minimized provided that the surgeon fully comprehend the mechanism of action of these procedures and adhere to technical perfectionism.
Key words: gastro-oesophageal reflux disease, medical therapy antireflux surgery proton pump inhibition, postfundoplications symptoms, laparoscopy
The predominance and the frequently chronic nature of gastro-oesophageal reflux disease (GORD) expose the clinician to the key question of which therapeutic strategy that should be chosen in each individual patient. In the short-term perspective no doubt modern medical therapy has documented its efficacy and attractiveness. This is true both for those GORD patients who present with erosive as well as non-erosive disease. When this therapeutic concept of selective acid secretory inhibition is translated into the long-term management perspective the following conclusions regarding proton pump inhibition (PPI) seem to be justified(1-13) .
- Most trials evaluating the efficacy of PPI: s has a trial design, including duration of therapy, not extending beyond 6 months.
- Around 65-90% of the patients are kept in clinical remission depending on the presence of oesophagitis at baseline and the severity of the oesophagitis as assessed by the Los Angeles system.
- There exists a rough association between the capacities of PPI: s to inhibit the parietal cells and the subsequent short and long-term efficacy of that therapy. Consequently the S-enanatiomer of omeprazole has been found to be more effective than the first generation of PPI: s.
- Patients with Barretts oesophagus appear to be more resistant to medical therapy, within the corresponding therapeutic time frames, with oeso-phagitis healing rates in the same range as reported in Los Angeles grade C and D cases. Based on the pathogenetic role of duodenal-alkaline juice components for the eventual occurrence and further development of columnar metaplasia of the oesophagus, it can easily be recognised that PPI therapy has its limitations in these patients.
- There is a relationship between the amount of acid refluxed into the oesophagus and the grading of the oesophagitis according to the Los Angeles system also related to the presence or absence of complications to GORD (such as Barretts oesophagus).
The question, which needs to be answered, is, however, whether the therapeutic ceiling is now reached, above which the acid inhibition concept cannot pass? Indeed it has to be mentioned that PPI therapy has effects also on the reflux of duodenal juice components into the oesophagus. Whether this is relevant for the interference with basic patogenetic mechanisms in e.g. the columnar metaplastic epithelium is as yet unknown. Based on corresponding background considerations the clinician frequently ask the question which therapeutic strategy that should be recommended in GORD patients who suffer from a chronic disease eventually requiring life long administration. Furthermore, there will be other factors that need to be incorporated into the decision making process such as respiratory complication to reflux, incomplete response to PPI and the willingness of the patient to continue PPI therapy for his or hers remaining life. Ultimately this leads to the question of whether surgical therapy can be a therapeutic option in similar GORD patients and how the prospects are and shall be for a long-term successful outcome. Some of the issues that are relevant to the long-term management of GORD can be summarized as follows: How effective is anti reflux surgery (ARS) compared to modern medical therapy in the long-term management of GORD?
What is the evidence supporting one operative approach before another? If the ARS strategy is endorsed how this surgery should be done to maximise GORD control and minimise side effects?
HOW EFFECTIVE IS ANTI REFLUX SURGERY (ARS) COMPARED TO MODERN MEDICAL THERAPY IN THE LONG-TERM MANAGEMENT OFGORD?
Before the late 1990: the grade A evidence strongly favoured the superiority of antireflux surgery (ARS) over medical therapy. There are, however, two major problems burdening these studies. First of all the medical comparator used is now totally outdated and second transthoracic surgical approaches are currently only exceptionally practised (14-16) . With the advent of PPI therapy the obvious question aroused if that therapeutic option could compete with ARS in terms of efficacy? This was a most pertinent question to be formulated since a comprehensive comparison should incorporate aspects on both to safety, practicalities confined to the therapy and side effects.
With the passage of time grade A evidence has emerged. These studies can basically be divided into two different categories. One is exemplified by the long-term follow up of the US Veteran study (17). Hereby an agency was recruited to search each individual 10 years after the randomisation and thereby completes the follow up. This follow up was apparently launched at a time point, not predefined in the original protocol. Consequently only a limited proportion of patients allocated to ARS were found and therefore the general applicability of these results is highly questionable. The methodological pitfalls are obvious when a study population becomes to dilute with apparent risk for both type II errors and I. One such example is the survival advantages in those US Veterans assigned to medical therapy (mostly PPI therapy), a finding which does not make sense neither from more general perspectives nor from the view point that prospective, controlled data have not demonstrated a similar detrimental effect of ARS (18,19). Anyhow data emerging from that former long-term follow up of patients randomised to ARS raised significant concern regarding the durability of the reflux control to which also could be added operation specific side effects.
The second study-representing grade A evidence is represented by the Nordic multi centre trial comparing open ARS with varying doses of omeprazole(18, 19). This study has now completed its 7-year follow up. Moreover a UK-based trials recently presented the short and long-term follow up of a cohort of selected GORD patients allocated either to laparoscopic Nissen (total) fundoplication or PPI therapy (20,21) These studies have a common denominator in that ARS is superior to PPI when it comes to reflux control. The outcome variables used in the different studies are, however, very different which may explain why there seemed to be more obvious differences in favour of ARS in the UK trials.
When comparing fundamentally different therapeutic strategies such as medical and surgical therapy it is of vital importance to recognise the complexity in capture data that allows a relevant comparison between respective strategies. It can be argued that a composite score may offer obvious advantageous before focusing on one or more disease specific symptom. In the Nordic trial a composite score, predefined as "treatment failure" was applied, whereupon the accumulation of those over time was analysed by use of survival statistics. The complexity confined to a similar comparison is also exemplified by the use of quality of life instruments(22-25) . These can be of either disease specific or of generic type. The latter revealed quite minor differences between omeprazole and open ARS whereas the disease specific or Gastrointestinal Symptom Rating Scale (GSRS) showed difference in favour of ARS in reflux dimensions whereas the post fundoplication side effects expressed themselves in other G-I dimensions within the same instrument. Although it can be concluded that ARS can very effectively compete with modern medical therapies it is a key issue how to minimise the side effects to fully recognise and more widely recommend it for selected patients.
Although ARS can only be a therapeutic alternative in a minority of patients suffering from chronic GORD, the issue of selecting the right patient is critical. Traditionally only patients with erosive GORD have been considered candidates for ARS. In fact most RCT: s within this research area has enrolled exclusively such patients. During the last decade it has, however, become apparent that at least half of GORD patients who present with significant intensity, frequency and duration of typical reflux symptoms do not have mucosal breaks of the time of diagnostic endoscopy. It is even questionable whether those individuals will ever develop erosive disease. In the early periods of ARS development many researcher questioned whether patients with non-erosive GORD, in who day time acid reflux were predominating, were good candidates for ARS (26-32) . With the passage of time solid grade B evidence has been accumulated to show that there are no obvious differences in the success rates between erosive and non-erosive GORD when submitted to ARS. The key importance of carrying out ambulatory 24 hour pH monitoring in this group of patients cannot be over emphasised before embarking on surgical therapy. Recently another problematic group of patients with alleged GORD has come in to focus. When patients, who are either poor-partial responders to PPI and even designated as non-responders, are submitted to advanced investigations including combined impedance, acid and bile reflux detection, intriguing findings have been reported(33). Apparently some of these patients present with mixed reflux, mild acid reflux to pure alkaline reflux. To this shall than be added a high symptom association probability. Challenging pilot data have been presented to show that the response to ARS may be most favourable even in these very difficult cases. At this stage the level of evidence for the role of surgery in these situations can only be classified, as C but future research will further clarify the picture.
It has been notoriously difficult to define the role of ARS in patients with proposed respiratory complications of GORD. It is most probable that the use of the same advanced, combined technologies, as described above, may sharpen our tools to significantly better select those patients who may benefit from a "complete" control of reflux as accomplished by an anti reflux repair. Until now we have to conclude that the level of evidence is at the best only B but more likely approaching a C when it comes to the efficiency of ARS by which such an operation deals with eventual respiratory complications to GORD. This is also true for chronic cough, posterior laryngitis, hoarseness as well as straightforward asthma and chronic bronchitis (34,35) .
The other extreme and complicated manifestation of GORD is represented by peptic strictures and Barretts oesophagus. Referring to the former a number of single institution series have been presented to which can be added a fair amount of case series (36-44) . Therefore the level of evidence supporting the efficacy of ARS in combination with endoscopic dilatation can only reach grade C.
Barretts oesophagus present many challenges to the surgeon. Traditionally this condition has been looked upon as a robust and frequently practised indication for ARS. In fact two randomised trials have been published to show the superiority of ARS over medical therapy, studies, which have incorporated follow up periods in the range of 5 years (15,45). This grade A evidence (with some limitation due to restricted number of patients enrolled) demonstrate the superiority of ARS both in term of histomorphological evaluation of the metaplastic epithelium as well as in terms of conventional clinical outcome variables. When it comes to the long-term outcome of ARS in Barretts cases the level of evidence is reduced to B and C depending on the sub optimal study designs and inconsistencies in data capturing. No doubt some researchers have reported quite dismal results by laparoscopic Nissen fundoplication advocating even the trans thoracic operative approaches in selected cases. More over even mutilating procedures such as vagotomy gastric resection with biliary diversion have been proposed. When collecting data from the literature(46-64), which can be classified as belonging to the category A-B, a picture emerges that reveals quite favourable and reassuring long-term results of conventional anti reflux repair in patients with Barretts oesophagus.
WHAT IS THE EVIDENCE SUPPORTING ONE OPERATIVE APPROACH BEFORE ANOTHER?
This topic has comprehensively been tackled in a recent meta analysis by Catarci and co-workers (65). Despite a quite impressive number of studies, carried out during the last decade, it became evident that significant scientific flaws burdened most study protocols(66-75) . This is illustrated by the lack of blinding in all but two protocols, profound under powering and sub optimal level of experience regarding the laparascopic technique. Bearing these drawbacks in mind it seems as if the following conclusions can be drawn.
The short and medium long-term results seem to be in the same range after laparoscopy compared to open anti reflux repair.
The immediate postoperative course is smoother after laparoscopy and the hospital stay somewhat shorter.vHealth economic analyses are few and incomplete, but significant advantages in favour of the laparoscopic strategy cannot be demonstrated due to longer operating time, expensive equipment and no clear cut reduction in indirect cost due driven by shorter sick leave during the postoperative recovery period.
With this information as a background and the fact that laparoscopy, as a surgical technique, has been accepted by and disseminated throughout the surgical community as well as among patients, it seems as if the question whether ARS should be carried out by minimal invasive technologies or not belongs to the category "non-issue".
No doubt, a total fundoplication, either modified from or constructed according to the principles originally outlined by Nissen, is the most frequently performed antireflux operation worldwide (1-3,76) . This surgical approach to the long-term control of gastrooesophageal reflux disease (GORD) has even further been popularised by the introduction of laparoscopy. The well-known downside of a total fundoplication is the mechanical side effects which seem to occur as a consequence of an over correction of the antireflux barrier in the gastrooesophageal junction (GOJ) area. This results in some degree of dysphagia, inability to belch, post prandial bloating and flatulence (77-81) . These issues are of crucial importance particularly in a clinical situation especially when effective medical therapeutic alternatives are available and harbor documented efficacy. To circumvent at least some of these drawbacks with the total fundoplications various forms of partial fundoplications have been launched and further explored to further ascertain their efficacy and mode of action (82-85) . In order to understand the eventual role of fundoplications in the surgical treatment of GORD one has to understand the essentials of pathogenetic mechanisms into which fundoplication operations interact. Furthermore, the mechanisms, which cause postfundoplication complaints have to be clarified, and the degree by which partial or total fundoplications interfere with those relevant to the occurrence of postoperative complaints.
The effects of partial versus total fundoplications have been investigated in 9 randomized clinical trials. 6 were open laparotomy operations and 3 trials used laparoscopic approach and these studies have been published from 1974 to 2002. To these are also added some single institution, prospective but uncontrolled observations (65,86-95). Concerning the partial fundoplications, the posterior partial type of operation was evaluated in 5 of these trials, the Hill repair in 2, and the Tind subtotal posterior wrap in 1 and the anterior fundoplication in 1 study. The scheduled postoperative follow-up period ranged from 4 months to 8 years. No significant differences were found between partial versus total fundoplications in terms of new onset dysphagia and recurrence of gastrooesohageal reflux symptoms. Re-operations for failure were carried out in 1.5% of those having a partial fundoplication compared to 9.6% of those having a total fundoplication, a difference which was considered to be significant (65) . In the largest randomized trial comparing a posterior with a total fundoplication, which covered more than 10 year of follow up, both procedures displayed the same level of reflux control. Based on the reassuring long-term follow-up data, it is difficult to understand why some investigators have found Toupet fundoplication not to be as successful as a total fundoplication, in severe cases of reflux disease particularly when performed by means of a laparoscopy. It cannot be denied, of course, that some procedures are more difficult to perform when modern minimal invasive techniques are applied. In a search for factors that may have affected the outcome after the respective procedures, it has been difficult to demonstrate that the severity, the duration of disease, hiatal closure by crural repair or body mass index had any impact on the level of long-term reflux control.
Survey of the controlled, clinical trial literature concerning posterior partial fundoplication shows that the level of clinical reflux control is not entirely similar to what can be reached by a total wrap, when studied by ambulatory 24 pH-monitoring. After the former procedure it is evident that the oesophageal acid exposure is reduced to near zero values. This contrasts to observations made in patients having a partial wrap where corresponding values are in the ranges considered to be normal.
Since prevention is the best strategy, not the least since we lack effective treatment of established severe postfundoplication symptoms, it is important to raise the question whether all partial fundoplications are followed but the same results? It seems beyond any doubt that less troubles and complaints of rectal flatulence follows a partial fundoplication compared to a total wrap (96-102). In a recent randomised clinical trial the questions was addressed whether there are important differences between an anterior and a posterior partial fundoplication in terms of reflux control and side effects (103). This trial incorporated almost 100 patients with a limited follow-up. Despite these drawbacks, significant differences were noted in favour of the posterior fundoplication regarding the level of reflux control. Even when only daytime acid exposure was objectively assessed, the outcome after laparoscopic anterior partial fundoplication (according to Watson) was found to be clearly inferior. Regarding side effects it was not possible to reveal any differences in obstructive complaints between the two partial fundoplications but interestingly enough significantly more patients reported an ability to vomit after the anterior fundoplication. This observation probably reflects the efficacy of the respective repair. Why should an anterior partial fundoplication function differently from a posterior one? The extent of the distal oesophageal body that is encircled by the actual wrap varies somewhat between the respective procedures. The posterior fundoplication elevates the abdominal portion of the oesophagus from its native bed in the hiatus and by necessity angulated the GOJ. The significance of this has to be better clarified but may have the potential to cause some esophageal outflow obstruction but it is totally unclear whether it contributes to a better mechanical barrier to prevent gastrooesophageal reflux. The anterior partial fundoplication performed and recently validated by Watson and co-workers from Australia(98), differs somewhat from that originally described in 1991(85). The message is, however clear, if a partial fundoplication is chosen it has to be a complete anterior 180° wrap but more studies are required to give firm guidance to the clinicians.
Surgery should always be looked upon as complementary to medical therapy in the long-term management of patients with chronic GORD.
GORD represents an increasing health problem among adults in the western world. Available medical therapies are effective and adequate for the control of disease manifestations in the great majority of GORD patients. For patients who have a suboptimal disease control under medical therapy and in those who for various reasons want to discuss an alternative to medical long-term therapy, the following message can be transmitted.
Antireflux surgery is a well-documented effective long-term therapeutic alternative to control GORD. The outcome after surgery is dependent on the experience and quality of the surgeon. These operations are safe but mortality can never attain a zero level and the morbidity has to be realized. Antirefiux surgery has to be centralized within each country. With the aim of optimizing the outcome of anti-reflux surgery, the surgeon has to perform and master a delicate act of balance on the choice between various fundoplication procedures. On one hand we have the total fundoplication with its proved efficacy regarding reflux control but with it associated mechanical side-effects leading to symptoms relating to the relative obstruction in the gastrooesophageal junction and the inability to vent air from the stomach and the sequel that follow. The posterior partial fundoplication has obvious advantages with less postfundoplication complaints without compromising the level of reflux control and can therefore often be recommended. Some studies present very promising results following anterior partial fundoplications but confirmative studies are warranted. The spectrum of postfundoplication symptoms can be minimized provided that the surgeon fully comprehend the mechanism of action of these procedures and adhere to technical perfectionism.
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