INDICATION FOR ANTIREFLUX SURGERY

INDICATION FOR ANTIREFLUX SURGERY

K.-H. Fuchs

• M. Fein

• J. Maroske

• W. Breithaupt

• I. Hammer

1 Department of Surgery, Markus-Krankenhaus, Frankfurter Diakonie-Kliniken, Frankfurt am Main, Germany 2 Department of Surgery, University of Würzburg, Würzburg, Germany

Introduction

It is an understandable request of gastroenterologists and surgeons in clinical practice to have a precise list of indications for antireflux surgery. This is rather difficult because it is in contrast to the multifactorial aspects that should be summarized in such a list of indications in order to respond to the different needs in a differentiated therapeutic spectrum to in- dividualize antireflux therapy. Currently there is a remarkable number of randomized trials available focusing on technical aspects of antireflux surgery [1]–[5]. However, there is very little evidence based information to justify certain factors for the indica- tion of antireflux surgery. This chapter reflects all the different aspects which are part of the manage- ment of gastroesophageal reflux disease and play a role in the indication for surgery.

The following factors are major issues in the di- scussion about the indication for laparoscopic anti- reflux surgery:

(1) a precise definition of the disease,

(2) the therapeutic aim of medical and surgical therapy,

(3) the analysis of results of different therapeutic strategies in order to identify patient subgroups which would benefit more from one or the other therapeutic regiment,

(4) a risk analysis and

(5) cost-benefit-considerations.

With the advent of minimal access technique antire- flux surgery has boomed in the past ten years. In most western countries, where the disease is more prevalent, the number of antireflux operations have more than tripled compared to the time before the introduction of minimal access techniques [6]–[9].

This has happened in a time, when the most potent antisecretory drugs were on the market, which stim-

ulates the controversal discussion between gastro- enterologists and surgeons regarding the indication for surgery [10], [11]. In several consensus projects in the past ten years indication for surgery has been more or less addressed but no widely accepted rules exist [12]–[14]. Therefore it is necessary to address this issue with a thorough analysis.

Definition of the disease

If an indication for surgery is established, one needs to base this on validated criteria. Most important are criteria for the presence of the disease. However, a general validated definition of GERD does not exist.

The disease can be defined by different components

and it all depends on the evaluation methods that

are used to detect disease. In general, gastroespha-

geal reflux disease could be defined as the process, in

which an abnormal amount of gastric contents or an

abnormal composition of a normal amount of gas-

tric fluid is moving back into the esophageal lumen

[15], [16]. This contact can cause symptoms and/or

erosions of the esophageal mucosa. The disease is

clinically present, when there is a risk for complica-

tions by excessive reflux and/or a significant impact

on health-related well-being because of the patients

reflux-related symptoms [14]. The process of reflux

and its damage is more complex and multifactorial

determined and even a complicated monitoring sys-

tem such as 24-hour-pH-monitoring, bilirubin-

monitoring and/or aspiration-analysis would still

have its limitations in determining the precise bor-

derline between normal and abnormal [17]–[19]. In

addition little is known about the ability of the

esophageal mucosa to resist this abnormal exposure

to toxic agents and little is known if a given patient

on surgical therapy of the disease, in the majority of the studies the presence of symptoms and esophagi- tis were used. Only in about one third of the studies, positive pH-monitoring as a more specific tool to verify pathologic esophageal acid exposure was ap- plicated for the definition. Only a few studies have relied on symptoms only, since symptoms can be an unreliable guide for the presence of gastroesophageal reflux disease [45].

On the other hand it must be emphasized that the presence of typical symptoms such as heartburn and acid or fluid regurgitation has been shown to be a very specific symptom with a positive predictive value for therapeutic success [46]. The authors of this study have shown that a good result of laparoscopic antire- flux surgery is more probable in patients with preop- erative presence of typical symptoms of reflux such as has a low or a high threshold of sensitivity to deve-

lop symptoms. As a consequence, it is impossible especially with limited economic resources to diag- nose and classify every patient in detail regarding all the above mentioned criteria. Instead, diagnostic work-up must be minimized to a few most useful and reasonable investigations in order to establish the decision for surgery.

In order to obtain more information about the definition of gastroesophageal reflux disease used in clinical practice, the definitions of the disease used in randomized trials for antireflux therapy were analysed. It is surprising what a variety of definitions for the disease have been used by several authors performing randomized trials in the past decades.

Table 1 demonstrates the difference in these defini- tions [20]–[44]. In 25 randomized trials, focusing

Table 1. Application of different criteria for definition of GERD in randomized trials

Author year Comparison Criteria for presence of GERD

DeMeester (1974) Nissen vs Belsey vs Hill symptoms, pH, endoscopy

Behar (1975) Angelchick vs surgery symptoms

Stuart (1989) Nissen vs Angelchick pH, symptoms, endo, mano

Thor (1989) Nissen vs Toupet symptoms, endo, mano

Kmiot (1991) Nissen vs Angelchick symptoms, pH, mano, endo
x-ray

Lundell (1991) Toupet vs Nissen symptoms, endoscopy, pH

Spechler (1992) H2 blocker vs Nissen symptoms, pH, mano, endo
x-ray

Eyre-Brook (1993) Nissen vs Angelchick symptoms, endoscopy, x-ray

Janssen (1993) Nissen vs . . . cardio . . . symptoms, endoscopy, pH

Hill (1994) Nissen vs Angelchick symptoms

Ortiz (1996) H2 blocker vs Nissen (Barrett) Barrett, pH

Lundell (1996) Nissen vs Toupet symptoms

Rydberg (1997) Nissen vs Toupet symptoms, mano, endo, pH

Watson (1997) lap. Nissen vs lap. Nissen . . . short gastrics manometry, endoscopy (selective pH)

Laws (1997) lap. Nissen vs lap. Toupet endo, mano, pH, x-ray

Anderson (1998) lap. nissen vs lap. anterior fundoplication endoscopy, pH, manometry

Lundell (1998) Omeprazol vs surgery symptoms, endoscopy

Rydberg (1999) Nissen vs Toupet (tailored) symptoms, endo, mano

Watson (1999) lap. Nissen vs lap. anterior symptoms, endoscopy, manometry (pat. selective) Luostarinen (1999) Nissen vs Nissen . . . symptoms, endoscopy, pH

Csendes (2000) Nissen vs Hill symptoms, mano, pH, endo

Nilsson (2000) lap. Nissen vs open Nissen endoscopy, pH

Bais (2000) lap. Nissen vs open Nissen symptoms, endoscopy, pH

Lundell (2001, continued) Omeprazol vs surgery symptoms, endoscopy

Luostarinen (2001) lap. AF vs open AF endoscopy, pH

Spechler (2001, continued) H2 blocker vs Nissen symptoms, pH, mano, endo, x-ray

heartburn and regurgitation, a preoperative positive test in 24-hour-esophageal-pH-monitoring showing a pathologic acid exposure in the esophagus and a po- sitive response to proton-pump-inhibitors, indicating that medical acid reduction will also reduce at least to some of the heartburn of the patient.

Regarding the diagnostic requirements, pH- monitoring and endoscopy are necessary for the ob- jective documentation of the disease [12], [13], [45].

With manometry other esophageal functional disorders can be excluded, which potentially cause a postoperative failure, especially spastic disorders [12], [13], [47]. Since a weak lower esophageal sphincter has been shown to be a prognostic bad sign regarding the future prognosis of GERD , one could use this criterium for the indication [48]. In addition, selection of patients with preoperative nor- mal lower esophageal sphincter parameters can be indicative for worse postoperative results [49]. How- ever, several studies have shown, that its predictive value for the postoperative results remains contro- versial and is therefore not recommended by gas- troenterologists [50], [51].

Currently gastroesophageal reflux diease has been redefined in three subgroups [14], [48]. These sub- groups are nonerosive reflux disease, erosive reflux disease and Barrett’s esophagus. This is a reasonable separation. However, it must be kept in mind that there is some overlapping especially between pa- tients with Barrett’s esophagus and erosive gastro- esophageal reflux disease, since it has been shown that this overlapping is present in at least 30% of the Barrett’s patients in several series [16], [19].

This classification of reflux patients is very im- portant because it reflects an increasing severity of the disease and this should be especially kept in mind by surgeons when discussing indication for a patient [13], [47]. There should be a general trend to operate severe cases of gastroesophageal reflux disease with a reduced quality of life because for most patients with a mild or moderate expression of the disease, proton-pump-inhibitors are well suffi- cient for symptom control.

For several years Barrett’s esophagus has been one of the main focuses within the complex of gas- troesophageal reflux disease due to its association with the adenocarcinoma of the cardia and the esophagus [19], [52]–[55]. Some authors have pro-

posed Barrett’s esophagus as a clear indication for surgery independent from reflux disease in order to prevent the development of adenocarcinoma [56].

From publications of recent years, it can be deducted that neither proton-pump-inhibitor therapy nor antireflux surgery can guarantee the prevention of the progression towards cancer [57]. In a recent meta-analysis it has been shown that the probability of developing cancer after antireflux surgery is not significant different from proton-pump-inhibitor therapy. Therefore, it must be stated that Barrett’s esophagus alone is not an indication for antireflux surgery. However, many patients with severe reflux disease also suffer from Barrett’s esophagus [16], [19], [58]. The severity of the underlying reflux dis- ease is a leading criteria for the establishment of an indication for antireflux surgery. Gastroenterologists have used the arguement against fundoplication since it would be less favorable to perform endo- scopic controlls in Barrett’s patients after a fundopli- cation. This argument is not valid, since experienced endoscopists have no problem to visualize the distal esophageal area and the gastroesophageal junction after a fundoplication.

Therapeutic aims

Currently there is even a controversal discussion between gastroenterologists and surgeons regarding the therapeutic aims in controling gastroesophageal reflux. Two decades ago the undoubtable aim of the therapy for the management was the healing of esophagitis, the removal of symptoms ant the remo- val and/or prevention of complications of the disease [15]. The presence of severe esophagitis was for many surgeons an indication for surgery. Today many gastroenterologists are convinced that the only criteria for therapeutic success is the removal of symptoms, may it occur with healing of esophagitis or not [14]. In surgical literature, both removal of symptoms and healing of esophagitis is necessary to determine a successful surgical therapy [12], [13]. In some papers even the documentation of a negative 24-hour-esophageal-pH-monitoring is used as definitive criteria for success.

This discussion is important in the controversy

about the indication for laparoscopic antireflux surgery,

the patients in the surgical group were taking pro- ton-pump-inhibitors. The authors concluded that the indication for surgery to exclude the necessity of long-term medication would be no longer valid. The results of this study were discussed very controver- sally since the spectrum of the patients treated in this trial was not representative for the average re- flux patients in western countries.

In a Scandinavian randomized trial, comparing medical versus surgical therapy, the measurement of success was time interval until a failure occured, in which the failure was defined as severe heartburn and regurgitation and/or esophagitis grade 2 as well as severe dysphagia and odynophagia [42]. The results of this trial showed, that if dosage of proton-pump- inhibitor Omeprazol is not restricted, there was no significant difference in failure rate between the anti- reflux surgery and Omeprazol. Recently the authors have presented seven year follow-up data, indicating that after seven years the slight advantage of the ope- rative versus Omeprazol treatment has reached the level of significance.

So far, there is no randomized trial available comparing laparoscopic antireflux surgery with pro- ton-pump-inhibitors. From the randomized trials, where laparoscopic antireflux surgery is involved, the results show much more favorable results regarding reflux recurrence than the above mentioned study with a recurrence rate of 30%. Table 2 demonstrates these results [59]–[61]. It can be summarized, that the failure rate is at approximately around 15% after three to five years if the operation is performed in centers that are able to do studies. It must be also emphasized that in none of these series regarding randomized studies patients died from laparoscopic antireflux surgery while in greater prospective or re- trospective series the mortality was approximately 0,2 to 0,6%.

Considering the prognosis of the disease, it has been shown that the severity of the disease is ac- companied with a higher incidence of complications [62]. It has also been proven that the presence of mechanical incompetence of the sphincter is associ- ated with a worse prognosis of the reflux disease over the years [48]. Severity of the disease, mechani- cal incompetence of the lower esophageal sphincter as well as the presence of a hiatal hernia are factors which can aggravate the disease and therefore are since many gastroenterologists have the opinion that

there is hardly any indication for antireflux surgery be- cause after antireflux surgery patients still need in a high percentage proton-pump-inhibitor therapy [44].

This question will be addressed in detail further below.

In summary, for the establishment of the indica- tion of a surgical procedure, gastroenterologists and surgeons should use more than one criteria for the definition and the verification of gastroesophageal reflux disease. In several consensus projects, it was documented that endoscopic signs of esophagitis should have been documented at present or in the past at least once. In addition, a positive 24-hour- pH-monitoring together with typical symptoms of the disease such as heartburn and/or regurgitation are important criteria for the presence of disease, which are needed for indication.

Analysis of results of laparoscopic antireflux surgery, identification of subgroups with therapeutic benefit

Failure to medical therapy was used as indication for some time. Today, this approach regarding the relation between therapeutic success and indication needs more differentiation. There has always been an attempt to identify certain subgroups of patients with gastro- esophageal reflux disease, who especially benefit from surgery compared to prolonged conservative therapy.

There are only two relevant randomized trials

comparing operative versus medical therapy [25],

[42], [44]. Both trials compared the open technique

in antireflux surgery to medical therapy. The first

trial was performed in the late 1980ies comparing

Nissen open fundoplication versus medical therapy

with antacids in H2-blocker [25]. The results of this

trial have shown an advantage for the Nissen fundo-

plication evaluating a clinical score as well as reduc-

tion in the presence of esophagitis after one year and

the mean of the percentage of esophageal acid expo-

sure after one year. Ten years later, in which many

patients had switched towards a proton-pump-

inhibitor treatment, these patients were re-evaluated

and did not show any significant difference when

comparing surgical patients without drugs and the

medical group patients under proton-pump-inhibi-

tor treatment [44]. However approximately 30% of

considered to be criteria which encourage the indi- cation for surgery [12], [13], [47], [63], [64].

Risk analysis

It must be emphasized that antireflux surgery is usu- ally a choice for elective surgery after well prepared diagnostic work-up in order to verify the criteria for indication of surgery. A risk analysis of the general condition of the patient should be added especially in patients with concomitant disease or in the el- derly. There is recent evidence that patients with concomitant disease and patients older than 70 years face a higher risk of probability of fatal outcome.

Therefore, the decision for surgery should be well adjusted according to a previous risk analysis based on the evaluation of the associated factors [65].

Cost benefit considerations

If one of the possible therapies would have a substantial better cost-benefit-ratio, this would have an influence on indication for surgery. In the past ten years several cost benefit analyses have been published, comparing medical and surgical therapy [66]–[68]. These analyses are usually based on the economic systems of the differ- ent countries where the studies were performed. The

results vary dramatically with a break even point, where costs of conservative therapy match with surgical ther- apy between two years and ten years. Only one study was based on a randomized trial in Scandinavia [68]. In this analysis, there were even differencies between the four different Scandinavian countries in costs for surgi- cal and medical therapy. In three of these countries sur- gical therapy was remarkably more expensive over three year follow-up basis compared to medical therapy. In one country these data were comparable. As a conse- quence with decreasing expenses for medical therapy because of the use of generic proton-pump-inhibitors and possible increasing cost for disposable instruments in laparoscopic surgery it seems to be difficult to use cost benefit analyses as an argument for the indication of laparoscopic surgery.

In countries where the economic advantage of short reconvalescence resulting in a short hospital stay and early return to work pays off regarding health insur- ance, laparoscopic surgery indeed could be advantage- ous. But this waits to be proven in large series.

Synapsis of factors for the indication of surgery

From all data available it must be concluded that gastroesophageal reflux disease can be treated suffi- ciently both by proton-pump-inhibitors and by anti-

Table 2. Randomized trials comparing open versus laparoscopic antireflux surgery

Author recruitment Random-group Morbidity N (%) Patient Reflux Dysphagia N (%) follow-up recurrence

N (%)

Laine Open 55 7 (13) 30 (12mo) 3 (10) 4 (13)

(1992–95) Lap 55 3 (8) 18 (12mo) 0 0

Heikkinen Open 20 5 (25) 19 (24mo) 2 (11) 11 (58)

(1995–96) Lap 22 3 (14) 19 (24mo) 0 9 (48)

Bais Open 46 8 (17) 46 (3mo) 1 (2) 0

(1997–98) Lap 57 5 (9) 57 (3mo) 2 (4) 7 (12)

Luostarinen Open 15 0 13 (17mo) 0 6 (46)

(1994–95) Lap 13 1 (8) 13 (17mo) 0 4 (31)

Chrysos Open 50 38 (76) 50 (12mo) 1 (2) 2 (4)

(1993–98) Lap 56 12 (21) 56 (12mo) 2 (4) 2 (4)

Nilsson Open 30 0 23 (60mo) 4 (17) 5 (22)

(1995–97) Lap 30 0 17 (60mo) 2 (12) 7 (41)

(2) Persistent or recurrent complications despite adequate proton-pump-inhibitor therapy such as persistent esophagitis, chronic ulceration and strictures.

(3) Side effects of medication despite changing medication with adequate dosage resulting in reduced quality of life due to symptoms.

(4) Anatomical changes such as large hiatal her- nias, completely incompetent lower esophageal sphincter, massive combined acid and duode- nogastroesophageal reflux.

A questionable indication is a patient with unwillin- gness to accept a long-term medication despite the fact that the adequate proton-pump-inhibitor ther- apy is successfull and reduces symptoms.

In summary, indication for antireflux surgery should be based on several facts such as the objecti- fied presence of the disease by sufficient diagnostic testing, the presence of symptoms to satisfy the pa- tients after surgery with the relief of symptoms, the sufficient and adequate medical treatment prior to surgery in order to ensure that all conservative at- tempts have been fulfilled, which usually increases the patient`s motivation for surgery. Prior to surgery, a risk analysis should be performed especially in pa- tients with concomitant disease and those patients above 70 years of age. In addition, it must be em- phasized that psychologic influences are possible on the patient’s clinical presentations of symptoms on esophagus and stomach and could overlap the clini- cal picture. If there is any doubt concerning this matter, psychologic evaluation is important.

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