Cecilia Engström

Comparison of Outcomes Twelve Years After Antireflux Surgery or Omeprazole Maintenance Therapy for Reflux Esophagitis

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.

Effects by daily long term provision of ghrelin to unselected weight-losing cancer patients: a randomized double-blind study.

The short‐term provision of ghrelin to patients with cancer indicates that there may be benefits from long‐term provision of ghrelin for the palliative treatment of weight‐losing cancer patients. This hypothesis was evaluated in a randomized, double‐blind, phase 2 study.

Twenty years of experience with laparoscopic antireflux surgery.

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.

Long-Term Outcome of Microscopic Esophagitis in Chronic GERD Patients Treated With Esomeprazole or Laparoscopic Antireflux Surgery in the LOTUS Trial

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.

Total or posterior partial fundoplication in the treatment of GERD: results of a randomized trial after 2 decades of follow-up.

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. ISRCTN59614486 http://www.controlled-trials.com/ISRCTN59614486/

Meta-analysis of two randomized controlled trials to identify long-term symptoms after division of the short gastric vessels during Nissen fundoplication

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.

Mechanical consequences of short gastric vessel division at the time of laparoscopic total fundoplication.

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.

Ten-year results of a randomized clinical trial of laparoscopic total fundoplication with or without division of the short gastric vessels.

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).

The dynamics of the oesophageal squamous epithelium ‘normalisation’ process in patients with gastro-oesophageal reflux disease treated with long-term acid suppression or anti-reflux surgery

Proton pump inhibitors and laparoscopic anti‐reflux surgery (LARS) offer long‐term symptom control to patients with gastro‐oesophageal reflux disease (GERD).

Impact of participation in randomized trials on outcome following surgery for gastro-oesophageal reflux.

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.