This study demonstrates that long-term (3 year) laparoscopic Nissen fundoplication and esomeprazole medication are similarly effective treatments for GORD, based on symptom evaluation, endoscopy and overall QoL measures. There were differences between the groups in relation to the outcome of other GI symptoms, severity of persistent reflux symptoms and overall vitality. In the surgical arm, the level of reflux symptom control, as also reflected in some QOLRAD dimensions, was somewhat better than on long-term medical treatment. This was, however, counterbalanced in the surgical group by those patients who suffered slightly more GI symptoms of a postfundoplication nature, such as abdominal pain and other functional symptoms. Postfundoplication problems are often regarded as a major stumbling block in the surgical approach to treating GORD but, within this trial, their frequency and degree were minimal, despite well-structured follow-up specifically designed to detect such problems. The success of both surgical and medical treatment arms, with 90% and 93% complete remission of symptoms, respectively (based on a strict definition of treatment failure), indicates that both treatments were highly effective.22–26
Our outcome data show dysphagia rates that differ only slightly after surgery compared with medical treatment. This may come as a surprise to some observers. Similarly, there was little difference in symptoms of epigastric pain and bloating, which to some extent was unexpected.17 26–29
Also the complication rates after the initial operation, at 3%, were exceptionally low.28–30
This high standard of surgery was achieved in 40 centres across Europe, so the results are applicable to any centre that can show itself to be sufficiently experienced and suitably trained in the technique of LARS.
The outcome variables, as currently assessed, suggest that improvements have been made in the long-term management of GORD relevant to both medical and surgical treatments. A similar trial comparing open ARS with the first generation of PPIs10
showed a lower degree of improvement in “like for like” symptom analyses. However, despite the similarities in design and outcome assessments, corresponding comparisons should be interpreted with caution. The current surgical outcomes when compared with previous studies could be due to a number of factors. First, we believe that the standardisation of the surgical technique within this trial is unique and not only contributes to the improved outcomes, but also shows that the actual operative techniques and details can be disseminated widely. As a consequence of this standardisation, all hiatal hernias were fully reduced and a crural repair was achieved to retain this anatomical correction.27
A second factor that may have contributed to the quality of the surgical results is the selection of centres with high volume and surgeons with established experience. Within each country such teams should be able to provide this quality in routine clinical practice. Thirdly, the laparoscopic technique may not only be superior to previous open techniques,28 31 32
but may also lend itself to critical review by the whole team, who can view (and record) the operation in all of its detail.
When considering medical treatment for GORD, there is a rationale for reliable and regular acid control for greater consistency in therapeutic response across the GORD population. The improved levels of acid inhibition and minimal side effects associated with the use of esomeprazole, irrespective of the severity of the GORD,11–15
most probably contributed to the outcome in the present study.
Both treatments were well tolerated and there were no safety concerns after 3 years of follow-up. Surgery has become safer with the introduction of laparoscopy, minimising complication risks (3% in this trial)32
and reducing the need for28 29 31
repair of subsequent incisional hernia (1% seen in this study so far). This study does not give any clear indication of the 5–10 year outcomes, but other reports indicate that the operation will be as durable as its open equivalent.32
In conclusion, this study has shown that in GORD patients, selected for inclusion in this trial, good quality surgical or medical treatment achieves very high standards of patient outcome. Both treatments were highly effective, safe and well tolerated.