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Background: Proton pump inhibitors and laparoscopic anti-reflux surgery (LARS) offer long-term symptom control to patients with gastro-oesophageal reflux disease (GERD)., Aim: To evaluate the process of 'normalisation' of the squamous epithelium morphology of the distal oesophagus on these therapies., Methods: In the LOTUS trial, 554 patients with chronic GERD were randomised to receive either esomeprazole (20-40 mg daily) or LARS. After 5 years, 372 patients remained in the study (esomeprazole, 192; LARS, 180). Biopsies were taken at the Z-line and 2 cm above, at baseline, 1, 3 and 5 years. A severity score was calculated based on: papillae elongation, basal cell hyperplasia, intercellular space dilatations and eosinophilic infiltration. The epithelial proliferative activity was assessed by Ki-67 immunohistochemistry., Results: A gradual improvement in all variables over 5 years was noted in both groups, at both the Z-line and 2 cm above. The severity score decreased from baseline at each subsequent time point in both groups (P < 0.001, all comparisons), attaining a normal level by 5 years. Corresponding decreases in Ki-67 expression were observed (P < 0.001, all comparisons). No significant differences were found between esomeprazole treatment and LARS. Neither baseline severity score nor Ki-67 expression predicted the risk of treatment failure., Conclusions: Five years of treatment is generally required before squamous epithelial cell morphology and proliferation are 'normalised' in patients with chronic GERD, despite endoscopic and symptomatic disease control. Control of the acid component of the refluxate seems to play the predominant role in restoring tissue morphology., (© 2017 John Wiley & Sons Ltd.)

Objective: To compare the effect of anti-reflux surgery (ARS) versus proton pump inhibitor therapy on lower oesophageal sphincter (LOS) function and oesophageal acid exposure in patients with chronic gastro-oesophageal reflux disease (GORD) over a decade of follow-up., Material and Methods: In this randomised, prospective, multicentre study we compared LOS pressure profiles, as well as oesophageal exposure to acid, at baseline and at 1 and 10 years after randomisation to either open ARS (n = 137) or long-term treatment with omeprazole (OME) 20-60 mg daily (n = 108)., Results: Median LOS resting pressure and abdominal length increased significantly and remained elevated in patients operated on with ARS, as opposed to those on OME. The proportion of total time (%) with oesophageal pH <4.0 decreased significantly in both the surgical and medical groups, and was significantly lower after 1 year in patients treated with ARS versus OME. After 10 years, oesophageal acid exposure was normalised in both groups, with no significant differences, and bilirubin exposure was within normal limits. After 10 years, patients with or without Barrett's oesophagus did not differ in acid reflux control between the two treatment options., Conclusions: Open ARS and OME were both effective in normalising acid reflux into the oesophagus even when studied over a period of 10 years. Anatomically and functionally the LOS was repaired durably by surgery, with increased resting pressure and abdominal length.

Background: There are few reports of large patient cohorts with long-term follow-up after laparoscopic antireflux surgery. This study was undertaken to evaluate changes in surgical practice and outcomes for laparoscopic antireflux surgery over a 20-year period., Methods: A standardized questionnaire, prospectively applied annually, was used to determine outcome for all patients undergoing laparoscopic fundoplication in two centres since commencing this procedure in 1991. Visual analogue scales ranging from 0 to 10 were used to assess symptoms of heartburn, dysphagia and satisfaction with overall outcome. Data were analysed to determine outcome across 20 years., Results: From 1991 to 2010, 2261 consecutive patients underwent laparoscopic fundoplication at the authors' institutions. Follow-up ranged from 1 to 19 (mean 7.6) years. Conversion to open surgery occurred in 73 operations (3.2 per cent). Revisional surgery was performed in 216 patients (9.6 per cent), within 12 months of the original operation in 116. There was a shift from Nissen to partial fundoplication across 20 years, and a recent decline in operations for reflux, offset by an increase in surgery for large hiatus hernia. Dysphagia and satisfaction scores were stable, and heartburn scores rose slightly across 15 years of follow-up. Heartburn scores were slightly higher and reoperation for reflux was more common after anterior partial fundoplication (P = 0.005), whereas dysphagia scores were lower and reoperation for dysphagia was less common (P < 0.001). At 10 years, satisfaction with outcome was similar for all fundoplication types., Conclusion: Laparoscopic Nissen and partial fundoplications proved to be durable and achieved good long-term outcomes. At earlier follow-up, dysphagia was less common but reflux more common after anterior partial fundoplication, although differences had largely disappeared by 10 years., (Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: Patients may be unwilling to participate in clinical trials if they perceive risks. Outcomes were evaluated following surgery for gastro-oesophageal reflux in patients recruited to randomized trials compared with patients not in trials., Methods: This study compared outcomes of patients who had surgery for reflux within or outside randomized trials between 1994 and 2009. The choice of procedure outside each trial was according to surgeon or patient preference. Clinical outcomes were determined 1 and 5 years after surgery using a standardized questionnaire, with analogue scales to assess heartburn, dysphagia and overall satisfaction. Subgroup analysis was undertaken for those aged less than 75 years undergoing laparoscopic Nissen fundoplication., Results: Some 417 patients entered six randomized trials evaluating surgery for reflux and 981 underwent surgery outside the trials. The trial group contained a higher proportion of men and younger patients, and patients in trials were more likely to have undergone Nissen fundoplication. At 1 year, patients in the trials had slightly lower heartburn scores and less abdominal bloating, but otherwise similar outcomes to those not in the trials. At 5 years there were no differences, except for a slightly higher dysphagia score for liquids in the trial group. For the subgroup analysis, demographic data were similar for both groups. There were no differences at 1 year, but at 5 years patients enrolled in the trials had higher scores for dysphagia for liquids and heartburn. All of the statistically significant differences were thought unlikely to be clinically relevant., Conclusion: Participation in a randomized trial assessing surgery for reflux did not influence outcomes., (Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: Randomized trials suggest that division of the short gastric vessels during Nissen fundoplication is unnecessary. Some trials report an increased risk of gas bloat symptoms following division of the short gastric vessels. In this study long-term follow-up data from the two largest randomized clinical trials of division versus no division of the short gastric vessels during laparoscopic Nissen fundoplication were combined to determine whether there were differences in late outcome., Methods: Patients with gastro-oesophageal reflux disease who underwent primary laparoscopic antireflux surgery and were included in two previously reported randomized trials were studied. Of 99 patients enrolled in the Swedish study and 102 in the Australian study, the short gastric vessels were divided in 104 and left intact in 97. Data sets were combined and late clinical outcomes analysed., Results: At 10-12 years' follow-up (mean 11.5 years) clinical data were obtained from 170 patients (86 with vessels divided, 84 undivided). Statistical analysis of the combined data set showed no significant differences in symptoms of heartburn or dysphagia, ability to belch or vomit, and use of antisecretory medications. Division of the short gastric vessels was associated with a higher rate of bloating symptoms (72 versus 48 per cent; P = 0.002)., Conclusion: Division of the short gastric vessels is followed by a slightly poorer clinical outcome at late follow-up after Nissen fundoplication. Surgeons should avoid dividing these vessels when undertaking a laparoscopic Nissen fundoplication., (Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Objective and Background: We lack long-term data (>10 years) on the efficacy of antireflux surgery when evaluated within the framework of randomized clinical trials Hereby we report the outcome of a randomized trial comparing open total (I) and a Toupet posterior partial fundoplication (II) performed between 1983 and 1991., Methods: One hundred and thirty-seven patients with gastroesophageal reflux disease and were enrolled into the study. The mean follow up has now reached 18 years. During these years 26% had died and 16% were unable to trace for follow up. Symptom outcomes were assessed by the use of validated self-reporting questionnaires., Results: Long-term control of heartburn and acid regurgitation (reported as no or mild symptoms) were reported by 80% and 82% after a total fundoplication (I) and corresponding figures were 87% and 90% after a partial posterior fundoplication (II), respectively (n.s.).The dysphagia scores were low 4.6 ± 1.3 (SEM) in group I and 3.3 ± 0.9 (SEM) in group II (n.s). The point prevalences of rectal flatulence and gas distension related complaints were of similar magnitude in the 2 groups. Twenty-three percentage of the patients in the total fundoplication group noted some ability to vomit compared with 31% in the partial posterior fundoplication group., Conclusions: Both a total and a partial posterior fundoplication maintain a high level of reflux control after 2 decades of follow up. The previously reported differences in mechanical side effects, in favor of the partial wrap, seemed to disappear over time., ((C) 2011 Lippincott Williams & Wilkins, Inc.)

Objectives: Gastroesophageal reflux disease (GERD)-associated changes in esophageal histology have been reported mainly after short-term medical antireflux therapy, and few individual lesions have been examined. We report detailed histological findings from the LOTUS study, at baseline and at 1 and 3 years after laparoscopic antireflux surgery (LARS) or esomeprazole treatment in patients with chronic GERD., Methods: LOTUS is a long-term, open, parallel-group, multicenter, randomized, controlled trial conducted in 11 European countries that compared LARS (n=248) with esomeprazole 20-40 mg daily (n=266). Biopsies from the distal esophagus 2 cm above the Z-line and at the Z-line were taken at baseline, and 1 and 3 years. The following lesions were assessed: basal cell hyperplasia (BCH), papillary elongation (PE), intercellular space dilatations (ISDs), intraepithelial eosinophils (EOSs), neutrophils, and necrosis/erosion. A severity score (SS, range 0-2) was calculated by taking the average score of all assessable lesions., Results: All lesions were more severe on Z-line biopsies than at 2 cm, and almost all improved significantly from baseline to 1 and 3 years. The average SS (from 2 cm to Z-line) changed from 0.95 to 0.57 (1 year) and to 0.49 (3 years) on esomeprazole, and from 0.91 to 0.56 (1 year) and to 0.52 (3 years) after LARS (P<0.001 for both treatments at 1 and 3 years, with no significant difference between treatments). The proportions of patients with severe histological changes decreased from approximately 50% at baseline to 11% at 3 years., Conclusions: Both continuous esomeprazole treatment and laparoscopic fundoplication are associated with significant and similar overall improvement in microscopic esophagitis after 1 year that is maintained at 3 years.

Background & Aims: It is important to evaluate the long-term effects of therapies for gastroesophageal reflux disease (GERD). In a 12-year study, we compared the effects of therapy with omeprazole with those of antireflux surgery., Methods: This open, parallel group study included 310 patients with esophagitis enrolled from outpatient clinics in Nordic countries. Of the 155 patients randomly assigned to each arm of the study, 154 received omeprazole (1 withdrew before therapy began), and 144 received surgery (11 withdrew before surgery). In patients who remained in remission after treatment, post-fundoplication complaints, other symptoms, and safety variables were assessed., Results: Of the patients enrolled in the study, 71 who were given omeprazole (46%) and 53 treated with surgery (37%) were followed for a 12-year follow-up period. At this time point, 53% of patients who underwent surgery remained in continuous remission, compared with 45% of patients given omeprazole with a dose adjustment (P = .022) and 40% without dose adjustment (P = .002). In addition, 38% of surgical patients required a change in therapeutic strategy (eg, to medical therapy or another operation), compared with 15% of those on omeprazole. Heartburn and regurgitation were significantly more common in patients given omeprazole, whereas dysphagia, rectal flatulence, and the inability to belch or vomit were significantly more common in surgical patients. The therapies were otherwise well-tolerated., Conclusions: As long-term therapeutic strategies for chronic GERD, surgery and omeprazole are effective and well-tolerated. Antireflux surgery is superior to omeprazole in controlling overall disease manifestations, but post-fundoplication complaints continue after surgery.

Background: Total fundoplication is the most common antireflux operation and can be performed with or without division of the short gastric vessels. There seems to be no difference in short-term outcomes with either approach. The aim of the study was to determine whether there were the long-term differences (after 10 years)., Methods: Ninety-nine patients were enrolled in the study. Short gastric vessels were divided in 52 patients (group 1) and left intact in 47 (group 2). Ten patients were lost to follow-up and seven patients died, leaving 42 patients for analysis in group 1 and 40 in group 2. All patients were evaluated by standardized quality of life questionnaires., Results: Three patients underwent reoperation within 5 years. Thirty-eight of 42 patients with a completely mobilized fundus reported no reflux symptoms, compared with 31 of 40 patients with intact vessels. There were no differences between the groups in other symptoms reflecting post-fundoplication complaints and quality of life outcomes., Conclusion: When total fundoplication is performed it makes no difference whether the fundus is mobilized or not. Both types of repair provide lasting control of reflux., (Copyright (c) 2008 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: Partial fundoplications have been popularized by their lower risk of mechanical side effects. The question then emerges whether a similar partial wrap should be done posterior or anterior to the distal esophagus? We therefore conducted a study to compare the long-term outcome of laparoscopic partial fundoplications constructed either as anterior (AF) or posterior (PF) repairs., Patients and Methods: Ninety-five patients were enrolled in a randomized clinical trial. After a mean follow up of 65 months, 43 AF and 45 PF patients remained in the study. The levels of reflux control and postfundoplication complaints were assessed by use of validated instruments., Results: A posterior fundoplication was found to provide significantly better control of reflux related symptoms (heartburn p < 0.0001, acid regurgitation p < 0.0001). This was also reflected in a significantly lower number of reoperations and need for antisecretory drug therapy. The earlier postoperative difference in postfundoplication symptoms had disappeared., Conclusions: A laparoscopic posterior partial fundoplication offers a high and durable level of disease control with few side effects. The current anterior type of repair cannot be recommended due to insufficient reflux control.

How best to surgically treat GERD is an unresolved issue. To increase our insights into the fundoplication procedures, functional consequences for the gastroesophageal junction of an anterior or a posterior partial fundoplication were studied by manometry. Patients were randomly selected from a larger study in a randomised comparison between posterior and anterior partial fundoplications. The manometric studies were done 12 months after respective procedures in 24 patients. The motor characteristics of the esophagus and lower esophageal sphincter (LES) function were determined by use of sleeve catheter manometry. The manometric characteristics of the esophageal body were similar in the study groups except for the ramp pressure. This was significantly higher in patients with posterior partial fundoplications. The posterior group had significantly longer total length (P < 0.02) as well as longer intra-abdominal portions (P = 0.07) of the LES while the basal tone, albeit numerically higher, did not reach statistical significance. Water-swallow induced LES relaxations reached lower nadir values in the anterior group (1.7 vs 2.7 mmHg). Gas distension triggered few transient LES relaxations in both study groups while common cavities were more frequently observed in those having an anterior partial wrap (P < 0.01). A posterior partial fundoplication is followed by manometric characteristics suggesting a well functioning antireflux barrier with some obstruction to bolus passage as well as restricted venting of air from the stomach. The manometric mechanisms behind the inferior reflux control achieved by a Watson type of anterior partial wrap has now been further elucidated.

Laparoscopic Nissen fundoplication is currently the most commonly practiced antireflux operation. Some adverse consequences of the operation remain in the form of mechanical side effects, labeled postfundoplication complaints, of which dysphagia and gas bloat seem to predominate. Measures have been suggested to counteract some of these and one frequently advocated has been division of the short gastric vessels to create a short-floppy wrap. The advantages of this are still debated, particularly in the long-term perspective. The aim of the present study was to evaluate the mechanical consequences of dividing all short gastric vessels at the time of a laparoscopic total fundoplication. Ninety-nine patients with chronic gastroesophageal reflux disease (GERD) were originally allocated on a random basis to have either all short gastric vessels divided or left intact at the time of a laparoscopic total fundoplication. A subsample of these patients, again selected at random, were recruited for a comprehensive manometric investigation 1 year after the operation. In this cohort, 12 patients had all short gastrics divided and in 12 patients, the wrap was done with intact vessels by use of the anterior portion of the fundus. Manometry was carried out by the use of a sleeve sensor to straddle the lower esophageal sphincter (LES), and gastric distension (750 ml air) was used to trigger transient LES relaxations (TLESR). The basal LES tone was similar in the two groups (14.2 +/- 2.4 and 18.8 +/- 4.3, mean +/- SE), respectively. Accordingly, all other relevant manometric variables were equal when the two groups were compared, except for the total number of TLESRs (triggered by gastric distension by air) that were significantly higher (p < 0.02) in patients having their short gastric vessels intact. Consequently, numerically more common cavities were recorded in the latter group. Very similar outcomes in terms of motor function of the LES and esophageal body were observed after a total fundoplication irrespective of whether a complete division of all gastric vessels had been carried out or not. However, after gastric distension with air, more TLESRs were recorded in the latter group suggesting a better maintained ability to vent air from the stomach.