Laparoscopic antireflux surgery for gastroesophageal reflux disease (gerd) results of a consensus development conference

Laparoscopic antireflux surgery for gastroesophageal reflux
disease (GERD)
Results of a Consensus Development Conference
Held at the Fourth International Congress of the European Association for Endoscopic Surgery(E.A.E.S.), Trondheim, Norway, June 21–24, 1996 Conference Organizers: E. Eypasch,1 E. Neugebauer2 with the support of F. Fischer1 and H. Troidl1
for the Scientific and Educational Committee of the European Association for Endoscopic Surgery (E.A.E.S.)
Expert Panel: A. L. Blum, Division de Gastro-Ente´rologie, Centre Hospitalier, Universitaire Vaudois (CHUV)
Lausanne (Switzerland); D. Collet, Department of Surgery, University of Bordeaux, (France); A. Cuschieri, Department
of Surgery, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland (U.K.); B. Dallemagne,
Department of Surgery, Saint Joseph Hospital, Lie`ge (Belgium); H. Feussner, Chirurgische Klinik u. Poliklinik rechts
der Isar, Universita¨t Mu¨nchen, Mu¨nchen (Germany); K.-H. Fuchs, Chirurgische Universita¨tsklinik und Poliklinik
Wu¨rzburg, Universita¨t Wu¨rzburg, Wu¨rzburg (Germany); H. Glise, Department of Surgery, Norra A
La¨nssjukhus, Trollha¨ttan (Sweden); C. K. Kum, Department of Surgery, National University Hospital, Singapore; T.
Lerut, Department of Thoracic Surgery, University Hospital Leuven, Leuven (Belgium); L. Lundell, Department of
Surgery, Sahlgren’s Hospital, University of Go¨teborg, Go¨teborg (Sweden); H. E. Myrvold, Department of Surgery,
Regionsykehuset, University of Trondheim, Trondheim (Norway); A. Peracchia, Department of Surgery, University of
Milan, School of Medicine, Milan (Italy); H. Petersen, Department of Medicine, Regionsykehuset, University of
Trondheim, Trondheim (Norway); J. J. B. van Lanschot, Academisch Ziekenhuis, Department of Surgery, University of
Amsterdam, Amsterdam (Netherlands) Representative of Prof. Dr. Tytgat (Netherlands)
1 Surgical Clinic Merheim, II Department of Surgery, University of Cologne, Ostermerheimer Str. 200, 51109 Cologne, Germany2 Biochemical and Experimental Division, II Department of Surgery, University of Cologne, Ostermerheimer Str. 200, 51109 Cologne, Germany Received: 29 November 1996/Accepted: 14 December 1996 Abstract
three phases: closed discussion in the expert group, public Background: Laparoscopic antireflux surgery is currently a discussion during the conference, and final closed discus- growing field in endoscopic surgery. The purpose of the Consensus Development Conference was to summarize the Results: Consensus statements were achieved on various state of the art of laparoscopic antireflux operations in June aspects of gastroesophageal reflux disease and current lap- aroscopic treatment with respect to indication for operation, Methods: Thirteen internationally known experts in gastro- technical details of laparoscopic procedures, failure of op- esophageal reflux disease were contacted by the conference erative treatment, and complete postoperative follow-up organization team and asked to participate in a Consensus evaluation. The strength of evidence in favor of laparoscop- Development Conference. Selection of the experts was ic antireflux procedures was based mainly on type II studies.
based on clinical expertise, academic activity, community A majority of the experts (6/10) concluded in an overall influence, and geographical location. According to the cri- assessment that laparoscopic antireflux procedures were teria for technology assessment, the experts had to weigh the current evidence on the basis of published results in the Conclusions: Further detailed studies in the future with literature. A preconsensus document was prepared and dis- careful outcome assessment are necessary to underline the tributed by the conference organization team. During the consensus that laparoscopic antireflux operations can be E.A.E.S. conference, a consensus document was prepared in Key words: Consensus development conferences — Lapa-
roscopic antireflux operations — Outcome assessment In the last 2 years, growing experience and enormous tech- and Troidl [190a]. Each panelist was asked to indicate what nical developments have made it possible for almost any level of development, in his opinion, laparoscopic antireflux abdominal operation to be performed via endoscopic sur- surgery has attained generally, and he was given a form gery. Laparoscopic cholecystectomy, appendectomy, and containing specific TA parameters relevant to the endo- hernia repair have been going through the characteristic life scopic procedure under assessment. In this form, the pan- cycle of technological innovations, and cholecystectomy, at elist was asked to indicate the status of the endoscopic pro- least, seems to have proven a definitive success. To evaluate cedure in comparison with conventional open procedures this life cycle, consensus conferences on these topics have and also to make a comparison between surgical and medi- been organized and performed by the E.A.E.S. [76b].
cal treatment of gastroesophageal reflux disease. The pan- Currently, the interest of endoscopic abdominal surgery elist’s view must have been supported by evidence in the is focusing on antireflux operation. This is documented by literature, and a reference list was mandatory for each item.
an increasing number of operations and publications in the Each panelist was given a list of relevant specific questions literature. The international societies such as the European pertaining to each procedure (indication, technical aspects, Association for Endoscopic Surgery (E.A.E.S.) have the re- training, postoperative evaluation, etc.). The panelists were sponsibility to provide a forum for discussion of new de- asked to provide brief answers with references. Guidelines velopments and to provide guidelines on best practice based for response were given and the panelists were asked to on the current state of knowledge. Therefore, a consensus send their initial evaluation back to the conference organiz- development conference on laparoscopic antireflux surgery ers 3 months prior to the conference.
for gastroesophageal reflux disease (GERD) was held, In Cologne, the congress organization team analyzed the which included discussion of some pathophysiological as- individual answers and compiled a preconsensus provi- pects of the disease. Based on the experience of previous consensus conferences (Madrid 1994), the process of the In particular, the input and comments of gastroenterolo- consensus development conference was slightly modified.
gists were incorporated to modify the preconsensus docu- The development process was concentrated on one sub- ject—reflux disease—and during the 4th International The preconsensus documents were posted to each pan- Meeting of the E.A.E.S., a long public discussion, including elist prior to the Trondheim meeting. During the Trondheim all aspects of the consensus document, was incorporated conference, in a 3-h session, the preconsensus document was scrutinized word by word and a version to be presented The methods and the results of this consensus confer- in the public session was prepared. The following day, a 2-h ence are presented in this comprehensive article.
public session took place, during which the text and thetables of the consensus document were read and discussedin great detail. A further 2-h postconference session of the panelists incorporated all suggestions made during the pub-lic session. The final postconsensus document was mailed At the Annual Meeting in Luxemburg in 1995, the joint to all expert participants, checked for mistakes and neces- session of the Scientific and Educational Committee of the sary corrections and finalized in September 1996. The full E.A.E.S. decided to hold a Consensus Development Con- text of the statements is given below.
ference (CDC) on laparoscopic antireflux surgery for gas-troesophageal reflux disease. The 4th International Con-gress of the E.A.E.S. in June 1996 in Trondheim should be Consensus Statements on Gastroesophageal Reflux
the forum for the public discussion and finalization of the Disease (GERD)
The Cologne group (E. Neugebauer, E. Eypasch, F.
Fischer, H. Troidl) was authorized to organize the CDC 1. What are the epidemiologic facts in GERD? according to general guidelines. The procedure chosen wasthe following: A small group of 13 internationally known In western countries, gastroesophageal reflux has a high experts was nominated by the Scientific Committee of the prevalence. In the United States and Europe, up to 44% of the adult population describe symptoms characteristic of 1. Clinical expertise in the field of endoscopic surgery GERD [124, 127, 242]. Troublesome symptoms character- istic of GERD occur in 10–15% with equal frequency in men and women. Men, however, seem to develop reflux esophagitis and complications of esophagitis more fre-quently than women [23].
Internationally well-known gastroenterologists were asked Data from the literature indicate that 10–50% of these to participate in the conference in the interest of a balanced subjects will need long-term treatment of some kind for discussion between internists and surgeons.
their symptoms and/or esophagitis [34, 195, 225, 242].
Prior to the conference, each panelist received a docu- The panelists agreed that the natural history of the dis- ment containing guidelines on how to estimate the strength ease varies widely from very benign and harmless reflux to of evidence in the literature for specific endoscopical pro- a disabling stage of the disease with severe symptoms and cedures and a document containing descriptions of the lev- morphological alterations. There are no good long-term data els of technology assessment (TA) according to Mosteller indicating how the natural history of the disease changes from one stage to the other and when and how complica- GERD is frequently classified as a synonym for esoph- tions (esophagitis, stricture, etc.) develop.
agitis, even though there is considerable evidence that only Topics which were the subject of considerable debate 60% of patients with reflux disease sustain damage of their but which could not be resolved during this conference are mucosa [8, 91, 150, 200, 231, 243]. The MUSE and Savary esophagitis classifications are currently used to stage dam-age, but they are poor for staging the disease [8].
● The cause of the increasing prevalence of esophagitis The modified AFP Score (Anatomy-Function- ● The cause of the increasing prevalence of Barrett’s Pathology) is an attempt to incorporate the presence of hia- tus hernia, reflux, and macroscopic and morphologic dam- ● The discrepancy between clinically and anatomically de- age into a classification [83]. However, this classification termined prevalence of Barrett’s esophagus lacks symptomatology and should be linked to a scoring ● The problem of ultrashort Barrett’s esophagus and its system for symptoms or quality of life; both scoring systems are extremely important for staging of the disease and for ● The relationship between Helicobacter pylori infection the indication for treatment [195a,b].
● Gastroesophageal reflux without esophagitis and abnor- ● The role of so-called alkaline reflux, which is currently 4. What establishes the diagnosis of the disease? A large variety of different symptoms are described in thecontext of gastroesophageal reflux disease, such as dyspha- 2. What is the current pathophysiological concept gia, pharyngeal pain, hoarseness, nausea, belching, epigas- tric pain, retrosternal pain, acid and food regurgitation, GERD is a multifactorial process in which esophageal and retrosternal burning, heartburn, retrosternal pressure, and gastric changes are involved [27, 65, 98, 251, 283].
coughing. The characteristic symptoms are heartburn Major causes involved in the pathophysiology are in- (retrosternal burning), regurgitation, pain, and respiratory competence of the lower esophageal sphincter expressed as symptoms [150, 204]. Symptoms are usually related to pos- low sphincter length and pressure, frequent transient lower esophageal sphincter relaxations, insufficient esophageal In addition, typical reflux patients may have symptoms peristalsis, altered esophageal mucosal resistance, delayed which are not located in the region of the esophagus. Pa- gastric emptying, and antroduodenal motility disorders with tients with heartburn may or may not have pathological pathologic duodenogastroesophageal reflux [27, 65, 92, 95, reflux. They may have reflux-type ‘‘nonulcer dyspepsia’’ or Several factors can play an aggravating role: stress, pos- The diagnostic tests that are needed must follow a cer- ture, obesity, pregnancy, dietary factors (e.g., fat, chocolate, tain algorithm. After the history and physical examination caffeine, fruit juice, peppermint, alcohol, spicy food), and of the patients, an upper gastrointestinal endoscopy is per- drugs (e.g., calcium antagonists, anticholinergics, theophyl- formed. A biopsy is taken if any abnormalities (stenosis, line, ␤-blockers, dihydropyridine). All these factors might strictures, Barrett’s, etc.) are found [8].
influence the pressure gradient from the abdomen to the If no morphologic evidence can be detected, only func- chest either by decreasing the lower esophageal sphincter or tional studies, e.g., measuring the acid exposure in the esophageal lumen by 24-h esophageal pH monitoring, are Other parts of the physiological mosaic that might con- helpful and indicated to detect excessive reflux [65]. It is of tribute to gastroesophageal reflux include the circadian vital importance that the pH electrode be accurately posi- rhythm of sphincter pressure, gastric and salivary secretion, tioned in relation to the lower esophageal sphincter (LES).
esophageal clearance mechanisms, as well as hiatal hernia Manometry is the only objective way to assess the location and Helicobacter pylori infection.
Ordinary esophageal radiologic studies (barium swal- low) are considered another mandatory basic imaging study 3. What is a useful definition of the disease? At the next level of investigation there are a number of A universally agreed upon scientific classification of GERD tests that look for the cause of pathologic reflux using is not yet available. The current model of gastroesophageal esophageal manometry as a basic investigative tool for this reflux disease sees it as an excessive exposure of the mu- purpose to assess lower esophageal sphincter and esopha- cosa to gastric contents (amount and composition) causing geal body function [27, 65, 91, 134, 283]. Video esopha- symptoms accompanied and/or caused by different patho- gography or esophageal emptying scintigraphy may also be physiological phenomena (sphincter pressure, peristalsis) leading to morphological changes (esophagitis, cell infiltra- Optional gastric function studies are 24-h gastric pH monitoring, photo-optic bilirubin assessment to assess duo- This implies an abnormal exposure to acid and/or other denogastroesophageal reflux, gastric emptying scintigraphy, gastric contents like bile and duodenal and pancreatic juice and antroduodenal manometry [81, 93, 95, 118, 146, 234].
in cases of a combined duodenogastroesophageal reflux.
Currently these gastric function studies are of scientific Table 1. Diagnostic test ranking order for GERD
Savary-Miller classification I, II, II, IV, V (M) metaplasia(U) ulcer(S) stricture(E) erosions Percentage time below pH 4 DeMeester score Overall lengthIntraabdominal lengthPressure (Transient LES relaxations) esophageal body a The concise numerical values for sphincter length, pressure, and relaxation depend on the respective manometric recording system used in the esophageal-function lab interest but they do not yet play a role in overall clinical Therefore the indication for surgery is based on the fol- patient management, apart from selected patients. The di- agnostic test ranking order is displayed in Table 1.
● Noncompliance of the patient with ongoing effective medical treatment. Reasons for noncompliance are pref- 5. What is the indication for treatment? erence, refusal, reduced quality of life, or drug depen- Pivotal criteria for the indication to medical treatment in gastroesophageal reflux disease are the patient’s symptoms, ● Persistent or recurrent esophagitis in spite of currently reduced quality of life, and the general condition of the optimal medical treatment and in association with symp- patient. When symptoms persist or recur after medication, ● Complications of the disease (stenoses, ulcers, and Bar- Mucosal damage (esophagitis) indicates a strong need rett’s esophagus [11, 68]) have a minor influence on the for medical treatment. If the symptoms persist, partially indication. Neither medical nor surgical treatment has persist, or recur after stopping medication, there is a good been shown to alter the extent of Barrett’s epithelium.
indication for doing functional studies. Gastrointestinal en- Therefore mainly symptoms and their relation to ongoing doscopy, already mentioned as the basic imaging examina- medical treatment play the major role in the indication for tion in GERD, should be performed in context with the surgery. However, antireflux surgery may reduce the need for subsequent endoscopic dilatations [21a]. The Indication for surgery is again centrally based on the participants pointed out that patients with symptoms com- patient’s symptoms, the duration of the symptoms, and the pletely resistant to antisecretory treatment with H - blockers or proton-pump inhibitors are bad candidates for Even after successful medical acid suppression the pa- surgery. In these individuals other diseases have to be tient can have persistent or recurrent symptoms of epigastric investigated carefully. On the contrary, good candidates pain and retrosternal pressure as well as food regurgitation for surgery should have a good response to antisecretory due to the incompetent cardia, insufficient peristalsis, and/or drugs. Thus, compliance and preference determine which treatment is chosen (conservative or operative).
With respect to indication, one important factor in the patient’s general condition is age. On the one hand, age 6. What are the essentials of laparoscopic surgical plays a role in the risks stratification when the individual risk of an operation is estimated together with the comor-bidity of the patient. On the other hand, age is an economic The goal of surgical treatment for GERD is to relieve the factor with respect to the break-even point between medical symptoms and prevent progression and complications of the disease creating a new anatomical high-pressure zone. This Concerning the indication for surgery, a differentiation must be achieved without dysphagia, which can occur when in the symptoms between heartburn and regurgitation is the outflow resistance of the reconstructed GE junction ex- considered important. (Medical treatment appears to be ceeds the peristaltic power of the body of the esophagus.
more effective for heartburn than for regurgitation.) Achievement of this goal requires an understanding of the natural history of GERD, the status of the patient’s esoph- Instruments: The examples of instruments are listed in ageal function, and a selection of the appropriate antireflux The earliest point at which one ought to collect func- Since the newly created structure is only a substitute for tional data after the operation is 6 months. The reasonable the lower esophageal sphincter, it is a matter of discussion time of assessment in the postsurgical follow-up phase is to what extent it can show physiological reactions (normal probably 1 year followed by 2-year intervals.
resting pressure, reaction to pharmacological stimuli, appro- Economic assessment is considered to be a significant priate relaxations during deglutition, etc.). There is no endpoint and is dealt with in a later section.
agreement on how surgical procedures work and restore the There is no evidence that laparoscopic surgery should be any better than conventional surgery. If laparoscopic sur- With respect to the details of the laparoscopic surgical gery is correctly performed, apart from the problems of procedures, the following degree of consensus was attained abdominal wall complications like hernia, infection, and by the panel (11 present participants) (yes/no): wound rupture, there should be no difference in outcome ascompared to the standard obtained in open surgery.
1. Is there a need for mobilization of the gastric fundus by Laparoscopic surgery, however, has the potential to re- dividing the short gastric vessels? (7/4) duce postoperative pain and limitations of daily activity.
2. Is there a need for dissection of the crura? (11/0)3. Is there a need for identification of the vagal trunks? In gastroesophageal reflux disease, lifelong medication is 4. Is there a need for removal of the esophageal fat pad? needed in many patients, because the disease persists but the acid reduction can take away the symptoms during the time 5. Is there a need for closure of the crura posteriorly? the medication is taken. The disease is treated by reducing the acid and not by treating or correcting the causes of the 6. Should nonabsorbable sutures be used (crura, wrap)? disease. This latter argument can be used by surgeons, since they mechanically restore the sphincter area and, therefore, 7. Should a large bougie (40–60 French) be used for cali- correct the most frequent defect associated with the disease.
In surgery, failure of a treatment is defined as the per- 8. Should objective assessment be performed (e.g., cali- sistence or recurrence of symptoms and/or objective patho- logic findings once the treatment phase is finished. In GERD, a definite failure is present when symptoms which are severe enough to require at least intermittent therapy 9. If there is normal peristalsis should one (heartburn, regurgitation) recur after treatment or when Routinely use a 360° short floppy fundoplication other serious problems (‘‘slipped Nissen,’’ severe gas bloat syndrome, dumping syndrome, etc.) arise and when func- Routinely use a partial fundoplication wrap? (2) tional studies document that symptoms are due to this prob- Use a short wrap equal to or shorter than 2.5 cm? (1) lem. Recurrence can occur with or without esophageal dam- 10. In cases of weak peristalsis, should there be a ‘‘tailored age (esophagitis). Professor Blum (Lausanne) suggested approach’’ (total or partial wrap)? (5/6)1 that further long-term outcome studies of medical and sur-gical treatment are needed.
7. Which are the important endpoints of treatment Quality-of-life measurements are able to differentiate whether and to what extent recurrent symptoms are reallyimpairing the patient’s quality of life.
The important endpoints for the success of conservative/ It was agreed upon that a distinction is necessary be- medical as well as surgical therapy must be a mosaic of tween the two types of failures of the operation: ‘‘the un- different criteria, since neither clinical symptoms, func- happy 5–10%’’ (i.e. slipped Nissen, etc.) and the 10–40% of tional criteria, nor the daily activity and quality-of-life as- individuals who only become aware of their dyspeptic sessment can be used solely to assess the therapeutic result symptoms postoperatively while the reflux-related symp- in this multifactorial disease process.
toms are treated. Dyspeptic symptoms occur in the normal Patients show great variety in demonstrating and ex- pressing the severity of clinical symptoms and, therefore, Some of the ‘‘postfundoplication symptoms’’ are pre- they alone are not a reliable guide. Functional criteria can be sent already before the operation and are due to the dyspep- assessed objectively, but may not be used in the decision- tic symptomatology associated with GERD.
making process without looking at the stage of mucosal Patients with failures should be worked up with the damage or morphological abnormalities (hiatus hernia, available diagnostic tests to detect the underlying cause of the failure. If there is mild recurrent reflux, it usually can be Complete evaluation includes assessment of symp-
treated by medication as long as the patient is satisfied with toms, daily activity, and quality of life—ideally, in every
this solution and his/her quality of life is good. In the case single patient.
of severe symptomatic recurrent reflux or other complica-tions, and if endoscopy shows visible esophagitis, the indi- cation for refundoplication after a thorough diagnostic During the public discussion, Professor Montori (Rome) mentioned the Angelchick prosthesis as a rare alternative—however, this was not dis- workup must be established. Surgeons very experienced in pathophysiology, diagnosis, and the surgical technique of Table 2a. Ratings of published literature on antireflux operations and medical treatment: strength of evidence in the literature-antireflux operations
Clinical randomized controlled studies with power and 32, 37, 49, 80, 87, 110, 130, 147, 163, 188, 217, 221, Case-control studiesCohort studies with literature controls 3, 4, 12, 19, 22, 36, 44, 47, 49, 55, 60, 61, 63, 72, 73, 95, 89, 107, 113, 126, 132, 159, 162, 163, 177, 184, 187, 190, 192, 208, 212, 213, 216, 219, 237, 255,267 Table 2b. Ratings of published literature on antireflux operations and medical treatment: strength of evidence in the literature-medical treatment
Clinical randomized controlled studies with power and 10, 17, 24, 26, 39, 56, 70, 112, 115, 116, 120, 121, 139, 151, 161, 168, 171, 180, 189, 202, 223, 224, 227,228, 240, 244, 246, 263, 265, 268, 270, 274, 282,284 Case-control studiesCohort studies with literature controls 16, 23, 50, 72, 117, 123, 135, 152, 157, 172, 174, 200, Reports of expert committeesCase series without controls the disease should perform these redo operations. Expert 11. Perspective of the analysis (patient, hospital, society) management of patients undergoing redo surgery for a be- 12. Health care system (socialized, private) nign condition is of extreme importance.
A special issue is the so-called break-even point betweenmedical and surgical treatment (duration and cost of medi-cal treatment vs laparoscopic antireflux treatment) [21b].
9. What are the issues in an economic evaluation? Ultimately, the results of medical or surgical treatment, especially with respect to age of the patient, should be trans- With respect to a complete economic evaluation the panel- lated into quality-adjusted life-years (QALYs) to differen- ists refer to the available literature [14a, 76a].
tiate which treatment is better for what age, comorbidity, Cost, cost minimization, and cost-effectiveness analyses of gastroesophageal reflux disease must take into accountthe following issues (list incomplete): Literature list with ratings of references
All literature submitted by the panelists as supportive evi- dence for their evaluation was compiled and rated. The ratings of the references are based on the panelists’ evalu- ation. The number of references is incomplete for the case 5. Frequency of restricted family or hobby activity at series without controls and anecdotal reports. The result of the panelists’ evaluation is given in Table 2a for the endo- 6. Assessment of job performance and restrictions due to scopic antireflux operations and in Table 2b for medical treatments (all options). The consensus statements are based 7. Costs of diagnostic workup including functional studies on these published results. A complete list of all references mentioned in Table 2a and 2b is included.
8. Costs of surgical intervention9. Costs for treatment of surgical complications 10. Costs of treatment of complications of maintenance Question 1. What stage of technological development
medical therapy, such as emergency hospital admis- are endoscopic antireflux operations at (in June 1996)?
sions, e.g., swallowing discomfort, bolus entrapment in The definitions for the stages in technological development follow the recommendations of the Committee for Evaluat- Table 3. Evaluation of the status of endoscopic antireflux surgery 1996: level attained and strength of evidence
1. FeasibilityTechnical performance, applicability, safety, complications, morbidity, mortality ● Benefit for the patient demonstrated in centers of excellence ● Benefit for the surgeon (shorter operating time, easier technique) 3. EffectivenessBenefit for the patient under normal clinical conditions, i.e., good results 4. CostsBenefit in terms of cost-effectiveness long operation times, frequency of thrombo-embolization, incidence of reoperations, altered indication for surgery, etc.c a Mosteller F (1985) Assessing Medical Technologies, National Academy Press, Washington, DC [190a]: and Troidl H (1995) Endoscopic Surgery—aFascinating Idea Requires Responsibility in Evaluation and Handling. Minimal Access Surgery, Surgical Technology International III (1995) pp 111–117[265a].
b Level attained to the definitions of the different grades.
c Percentage of consensus was calculated by dividing the number of panelists who voted 0, I, II or III by total number of panelists who submitted theirevaluation forms.
Table 4a. Antireflux surgery vs open conventional procedures: evaluation of feasibility parameters by all panelists at CDC in Trondheim*
Assessment based on evidence in the literature FeasibilitySafety/intraop. adverse events—Gastric or esophageal leaks/ Table 4b. Antireflux surgery vs open conventional procedures: evaluation of efficacy parameters by all panelists prior to CDC in Trondheim
Assessment based on evidence in the literature a Comparison: laparoscopic fundoplication techniques vs open conventional procedure.
b Percentage of consensus was calculated by dividing the number of panelists who voted better (probably and definitely), similar, or worse (probably anddefinitely) by the total number of panelists who submitted their evaluation forms.
c Refer to Table 1.
ing Medical Technologies in Clinical Use (190a) (Mosteller antireflux surgery should be recommended in centers with- F., 1985) extended by criteria introduced by Troidl (1995).
sufficient experience and an adequate number of individuals The panel’s evaluation as to the attainment of each techno- with the disease. Randomized controlled studies are recom- logical stage by endoscopic antireflux surgery, together mended to compare medical vs laparoscopic surgical treat- with the strength of evidence in the literature, is presented in ment and partial vs total fundoplication wraps.
Technical performance and applicability were demon- strated by several authors as early as 1992/1993. The results Question 2. What is the current status of laparoscopic
on safety, complications, morbidity, and mortality data de- antireflux surgery vs open conventional procedures in
pend on the learning phase (>50 cases) of the operations.
terms of feasibility and efficacy parameters?
The complication, reoperation, and conversion rates arehigher in the first 20 cases of an individual surgeon. It is A table with specific parameters relevant to open and lap- strongly advocated that experienced supervision be sought aroscopic antireflux procedures summarizes the current sta- by surgeons beginning laparoscopic fundoplication during tus (Table 4). The evaluation is mainly based on type I and their first 20 procedures [278,a,b]. Data on efficacy (benefit type II studies (see list of references).
for the patient) demonstrated in centers of excellence were The results show that safety is comparable and rather based on type II studies. The benefit for the surgeon in terms favorable compared to the open technique. The incidence of elegance, ease, and speed of the procedure is not yet clear for complications, morbidity, and mortality is similar to the cut. The operation time is the same or longer, and the tech- open technique once the learning phase has been surpassed.
nique is harder initially—however, the view of the operat- For specific intraoperative and postoperative adverse events ing field is better. The effectiveness data are still insuffi- cient, long-term results are missing, and the results reported In terms of efficacy, significant advantages of the endo- come mainly from interested centers and multicenter stud- scopic antireflux operations are: less postoperative pain, ies. It is important to audit continually the results of anti- shorter hospital stay, and earlier return to normal activities reflux operations, especially because different techniques are used. The economic evaluation of laparoscopic antire- In general, laparoscopic antireflux surgery has advan- flux surgery is still premature (few data from small studies tages over open conventional procedures if performed by only). Future studies are recommended in different health care systems, assessing the relative economic advantages of Laparoscopic antireflux surgery has the potential to im- laparoscopic antireflux surgery in comparison to the avail- prove reflux treatment provided that appropriate diagnostic facilities for functional esophageal studies and adequately A major issue of ethical concern is the altered indication trained and dedicated surgeons are available.
for surgery. A change of indication might produce more costand harm in inappropriately selected patients. Laparoscopic Acknowledgments. The organizers would like to thank the panelists of the conference for their tremendous work and input in reaching these consen- gastroesophageal reflux: laparoscopic placement of the Angelchik sus statements. We appreciate very much the time and energy spent to prosthesis in pigs. Surg Endosc 5: 123–126 21a. Bonavina L, Bardini R, Baessato M, Peracchia A (1993) Surgical The organization of the conference was only possible with the generous treatment of reflux stricture of the esophagus. Br J Surg 80: 317 support of Professor Myrvold (Trondheim), the excellent assistance of Mrs 21b. Boom VDG, Go PMMYH, Hameeteman W, Dallemagne B (1996) Karin Nasskau (Cologne) and Dr. Rolf Lefering (Cologne) who strongly Costeffectiveness of medical versus surgical treatment in patients supported the conference evaluations.
with severe or refractory gastroesophageal reflux in the Netherlands.
Thanks also to the E.A.E.S. for their financial support and to Professor Myrvold, the President of the 4th International Conference of the E.A.E.S.
22. Bittner HB, Meyers WC, Brazer SR, Pappas TN (1944) Laparoscopic for enabling and supporting the conference.
Nissen fundoplication: operative results and short-term follow-up.
Am J Surg 167: 193–200 23. Blum AL (1990) Treatment of acid-related disorders with gastric acid References
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Literature not mentioned in the statements but discussed during the con- ference is also cited in this list of references.
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