Gastro-oesophageal reflux disease
Authors: Andrew C de Beaux, David I Watson, Glyn G Jamieson
Journal: The Lancet (2000)

—We admire the effort that J E Bais and colleagues (Jan 15, p 170)1Bais JE Bartelsman JFWM Bonjer HJ et al.Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial.Lancet. 2000; 355: 170-174Summary Full Text Full Text PDF PubMed Scopus (258) Google Scholar have put into the assessment of open versus laparoscopic Nissen fundoplication. Any randomised trial is difficult to perform well and yet it is important to evaluate new procedures, and hence studies such as the one reported are valuable. Therefore, it is a pity that the grounds for termination of the trial at an early stage may have been unsound. It is possible that as longerterm data become available, or if different study end points were to be applied, different conclusions might be drawn. The decision to stop the trial was based primarily on whether or not patients had dysphagia postoperatively. The investigators are critical in their discussion of other published series for inconsistent definitions for dysphagia, and we agree that such definition is difficult. However, the same criticism can be applied to their trial, because no definition of dysphagia is provided, nor is there a description of the methodology applied for the assessment of dysphagia. We are aware from our own follow-up of patients undergoing antireflux surgery within randomised trials2Watson DI Pike GK Baigrie RJ et al.Prospective double blind randomised trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels.Ann Surg. 1997; 226: 642-652Crossref PubMed Scopus (236) Google Scholar, 3Watson DI Jamieson GG Pike GK Davies N Richardson M Devitt PG A prospective randomised double blind trial between laparoscopic Nissen fundoplication and anterior partial fundoplication.Br J Surg. 1999; 86: 123-130Crossref PubMed Scopus (205) Google Scholar that how and who asks questions, and the scoring system which is used, can influence the apparent incidence of post-operative symptoms, such as dysphagia. Furthermore, our experience with prospective follow-up of more than 900 laparoscopic fundoplications has shown that most patients who undergo a Nissen fundoplication have some dysphagia 3 months after Nissen fundoplication.2Watson DI Pike GK Baigrie RJ et al.Prospective double blind randomised trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels.Ann Surg. 1997; 226: 642-652Crossref PubMed Scopus (236) Google Scholar, 3Watson DI Jamieson GG Pike GK Davies N Richardson M Devitt PG A prospective randomised double blind trial between laparoscopic Nissen fundoplication and anterior partial fundoplication.Br J Surg. 1999; 86: 123-130Crossref PubMed Scopus (205) Google Scholar, 4Watson DI Jamieson GG Baigrie RJ Mathew G Devitt PG Game PA Laparoscopic surgery for gastro-oesophageal reflux: beyond the learning curve.Br J Surg. 1996; 83: 1284-1287Crossref PubMed Scopus (107) Google Scholar This symptom usually subsides as more time passes, and hence we contend that a follow-up period of 3 months is too short to allow adequate conclusions about dysphagia to be made. Dysphagia is common before antireflux surgery, occurring in up to 40% of patients with gastrooesophageal reflux disease,2Watson DI Pike GK Baigrie RJ et al.Prospective double blind randomised trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels.Ann Surg. 1997; 226: 642-652Crossref PubMed Scopus (236) Google Scholar, 3Watson DI Jamieson GG Pike GK Davies N Richardson M Devitt PG A prospective randomised double blind trial between laparoscopic Nissen fundoplication and anterior partial fundoplication.Br J Surg. 1999; 86: 123-130Crossref PubMed Scopus (205) Google Scholar and it is usually more common at 3 months after open Nissen fundoplication5DeMeester TR Johnson LF Kent AH Evaluation of current operations for the prevention of gastroesophageal reflux.Ann Surg. 1974; 180: 511-525Crossref PubMed Scopus (269) Google Scholar than reported in other studies. If outcomes are looked at in another way, one could focus on the apparent doubling of complications following open surgery, and report an advantage for laparoscopic fundoplication. While the investigators assure us of the experience of the surgeons carrying out or supervising the laparoscopic procedures, 54 patients were recruited from one institution, the remaining 49 patients were recruited from eight different hospitals over 19 months—ie, on average of one case every 3 months for each hospital. Does this figure reflect the true workload of these hospitals? If not, what proportion of patients were not recruited to the trial and why, and what operations were undertaken in these patients? Since the statistics in the trial have been carefully planned it is also surprising that the investigators do not acknowledge the possibility that they may be dealing with a type II statistical error. We are disappointed that a worthwhile opportunity to add to the literature on laparoscopic versus open fundoplication had been diminished by early and possibly unnecessary termination. Gastro-oesophageal reflux diseaseAuthor's reply Full-Text PDF