Costs of medications used to treat inflammatory bowel disease.

BACKGROUND: Inflammatory bowel disease (IBD), mainly Crohn's disease (CD) and ulcerative colitis (UC) are chronic diseases causing a lifelong burden and often need sustained treatment throughout a patient's life. Both the incidence and prevalence of IBD has increased in the last decade. Evidence showing the drug costs to IBD patients in Finland is limited. No earlier study has evaluated the drug costs of IBD patients in Finland. Here, we thoroughly assessed these costs. METHODS: A structured questionnaire, hospital records and national registers were combined to comprehensively assess the actual costs of drug purchases made by IBD patients. The study sample comprised 561 patients. RESULTS: Total annual mean drug costs were 1428€ per patient. CD patients had higher annual costs than UC patients at 2369€ and 902€, respectively. CD patients also had higher costs in the immunosuppressant, corticosteroid, and biologic subgroup analyses. In addition, C-reactive protein, serum albumin and fecal calprotectin levels had a correlation with costs if the patient had needed corticosteroids. In addition, women reported having a worse quality of life (QoL) but had lower total costs. CONCLUSIONS: Pharmaceutical drugs are major factors that affect the costs of IBD treatment, and the increased use of biologics has raised these costs.

Inflammatory bowel disease: perceived impact on leisure-time activities.

OBJECTIVE: Inflammatory bowel disease, consisting of Crohn's disease and ulcerative colitis, is known to negatively impact an individual's quality of life. Leisure-time activities are an important part of life by creating and strengthening social networks. The aim of this study was to thoroughly evaluate the perceived impact of inflammatory bowel disease on leisure-time activities by quantifying limitations in activities caused by the disease. METHODS: A structured questionnaire, hospital records and national registers were combined to assess limitations caused by the disease in a patient's leisure-time activities. The final study sample was 561 patients. RESULTS: More than half of the patients (52.8%) reported that IBD had caused limitations in their leisure-time activities. Women perceived that their limitations were greater when compared to the reports by men. One-third of the patients (33.3%) reported reducing and 17.6% abandoning at least one leisure-time activity due to their disease. Most often mentioned activities that were reduced and abandoned were physical activities. The IBDQ32 score had a significant correlation with all of the studied outcomes. Laboratory tests results and the patient's age or the level of income did not correlate with limitations in leisure-time activities. CONCLUSIONS: In conclusion, this study showed that patients with inflammatory bowel disease perceived a marked limitation in their leisure-time activities due to their disease.

Dose-escalation of adalimumab, golimumab or ustekinumab in inflammatory bowel diseases: characterization and implications in real-life clinical practice.

OBJECTIVES: Dose-escalation is a common practice to optimize treatment with subcutaneously administered biologicals in Crohn's disease (CD) and ulcerative colitis (UC). However, limited data is available on the extent of dose-escalation in real-life. Here, we analyzed treatment persistence, dose-escalation, concomitant corticosteroid use, and costs of adalimumab, golimumab, and ustekinumab in inflammatory bowel diseases (IBD). METHODS: This was a nationwide, retrospective, non-interventional registry study. All adult patients who were diagnosed with CD or UC and had purchased adalimumab, golimumab, or ustekinumab from Finnish pharmacies between 2008 and 2018 were included in the study and followed up for 24 months after treatment initiation. RESULTS: A total of 2884 patients were included in the analyses. For adalimumab, treatment persistence was higher for CD patients compared to UC patients both at months 12 (46.2% versus 37.1%; p < .0001) and 24 (26.1% versus 19.7%; p < 0.0001). For golimumab (UC), treatment persistence was 48.3% at month 12 and 28.1% at month 24. The 12-month treatment persistence rate for patients on ustekinumab (CD) was 47.1%. Cumulative doses exceeding the regular dosing according to the summary of product characteristics (SPC), was observed for adalimumab in CD during the first 6 months of treatment (62.9% of the treatment periods), golimumab in the later stages of the UC treatment (52-54% of treatment periods at months 7-24), and ustekinumab during the first 6 months (70.7%). CONCLUSIONS: Based on this study, dose-escalation of subcutaneously administered biologicals is a common clinical practice in IBD. This has implications for treatment costs, use of concomitant medications, and treatment outcomes.

Inflammatory bowel disease-related economic costs due to presenteeism and absenteeism.

BACKGROUND: Inflammatory bowel disease (IBD), consisting of Crohn's disease and ulcerative colitis, can be a lifelong burden generating high costs to an economic system. Data regarding the cost of workplace presenteeism and absenteeism in workers with IBD are limited. Our objective was to assess these costs in employed adults. METHODS: A structured questionnaire, hospital records and national registers were combined to assess the economic costs involved with workplace presenteeism and absenteeism in employed patients. Our final sample comprised 320 IBD patients. The costs were calculated as productivity-loss costs by using a Human Capital Approach. RESULTS: Due to IBD, the mean annual economic costs of workplace presenteeism were €643.90/patient, and mean annual absenteeism costs were €740.90/patient. Women had higher costs (€955/patient/year) from absenteeism compared to men (€531/patient/year) especially when working blue-collar jobs. These findings were also evident in presenteeism. CD and UC patients had similar total costs due to presenteeism and absenteeism. The use of biologics did not have a major impact on these costs. CONCLUSION: IBD patients had moderate economic costs from workplace presenteeism and absenteeism. Interestingly, women, working blue-collar jobs, had higher costs than men.

The value of combined positron emission tomography/magnetic resonance imaging to diagnose inflammatory bowel disease: a prospective study.

BACKGROUND: The clinical utility of positron emission tomography/magnetic resonance imaging (PET/MRI) in comparison to standard work-up with patients with known or suspected inflammatory bowel disease (IBD) is unknown. PURPOSE: To evaluate the value of 18F-fluorodeoxyglucose (18F-FDG) PET/MRI in the diagnostics of IBD and further compare the data obtained using PET/MRI to histological findings. MATERIALS AND METHODS: Ten patients with relapse in IBD or with symptoms of suspected IBD were recruited either from a gastroenterology outpatient clinic or from a hospital ward. Intestinal inflammation was assessed with histology and 18F-FDG PET/MRI. Maximum standard uptake values (SUVmax) were calculated in six regions of the intestine (small bowel, ascending, transverse, descending and sigmoid colon, and rectum) and compared to histological analysis of inflammation activity. RESULTS: The study showed that both the inflammation activity (P = 0.008) and the region of the biopsy in the intestine (P = 0.015) had a significant effect on SUV. SUVs obtained from severe inflammation activity emerged significantly from the background (P = 0.006). In addition, the SUVs obtained from moderate inflammation raised from background, but the difference was not statistically significant (P = 0.083), while SUVs of mild inflammation were at the same level with SUVs of normal bowel wall (P = 0.988). CONCLUSION: 18F-FDG PET/MRI is a promising method of detecting especially severe inflammatory bowel lesions. More data are required to define its sensitivity and specificity.

Healthcare resource utilization and treatment costs of Finnish chronic inflammatory bowel disease patients treated with infliximab.

Objectives: Inflammatory bowel disease (IBD) is associated with a high economic burden to society due to its early onset and chronic character. Here, we set out to characterize healthcare resource utilization and associated costs in Crohn's disease (CD) and ulcerative colitis (UC) patients with infliximab treatment, the most widely used first-line biologic agent in Finland, in a real-world clinical setting. Methods: This was a retrospective, non-interventional single-center study. Infliximab was administered in routine care, and data were collected retrospectively from electronic health records. All adult anti-TNF naïve CD or UC patients whose infliximab treatment was initiated at the Hospital District of Southwest Finland between the years of 2014 and 2016 were included in the study. Each patient was followed-up for 12 months after the initiation of infliximab treatment. Results: A total of 155 patients were included (45 CD, 110 UC). Altogether, 60.0% (n = 27) of all CD patients and 43.6% (n = 48) of all UC patients persisted on infliximab therapy 12 months after treatment initiation. The total cost was similar for both CD and UC cohorts (CD, €10,243; UC, €10,770), infliximab treatment being the highest individual cost (60.3% of the total cost in CD; 53.4% in UC). The mean number of infliximab infusions during the 12-month follow-up was 7.0 for CD and 6.5 for UC patients. Conclusions: IBD causes a significant burden to the Finnish healthcare system. This study provides a detailed characterization of the cost landscape of IBD and contributes to optimizing treatment strategies and healthcare resource use in the biosimilar era.

Should hepatocellular cancer by screened in Finland?

Almost 2 000 people die each year from the adverse effects of alcohol use in Finland. Liver cirrhosis is the cause of death in half of the cases. Although the annual risk of hepatocellular cancer for a cirrhosis patient is 1 to 4%, more than 95% of the deaths result from complications caused by the cirrhosis, not the cancer. It seems that nontargeted screening of hepatocellular cancer for those affected with alcoholic cirrhosis or nonalcoholic steatohepatitis is not cost-effective. Screening may, however, be advisable when the risk of cancer is high, provided that treatment of a detected cancer is possible.

[Gastro-oesophageal reflux disease--a common and benign but costly disease]. / Refluksitauti --hyvänlaatuinen mutta kallis sairaus.

The prevalence of GORD has increased. GORD causes significant impairment of the quality of life and is the most costly gastrointestinal disease. In patients aged under 55 years and without alarming symptoms and signs, treatment may be started without endoscopy. Proton pump inhibitors are the most effective medical treatment. Most GORD patients have normal oesophageal findings on endoscopy. If medical treatment fails, the diagnosis of GORD should be verified. The indications for surgical treatment, i.e. laparoscopic fundoplication, include the failure of medical treatment, severe erosive esophagitis, regurgitation as the main symptom, and severe GORD with large hiatal hernia.

Effect of inflammatory bowel diseases on household chores.

More than a half of inflammatory bowel disease (IBD) patients experienced a moderate negative effect on their household chores due to their IBD. The negative effect was more common amongst women.

Keratin 7 expression in different anatomical parts of colonic epithelium in inflammatory bowel diseases and its prognostic value: a 3-year follow-up study.

The diagnosis of inflammatory bowel diseases (IBD) may be challenging and their clinical course, characterized by relapses and spontaneous or drug-induced remissions, is difficult to predict. Novel prognostic biomarkers are needed. Keratin 7 (K7) is a cytoskeletal intermediate filament protein which is not normally expressed in the colonic epithelium. It was recently shown that K7 expression in the colonic epithelium is associated with ulcerative colitis and Crohn's disease, the two main subtypes of IBD. Here we investigated IBD associated K7 neo-expression in different regions of colon and terminal ileum. The correlation of the K7 expression with the inflammatory activity of the epithelium was analyzed in each region. The prognostic value of K7 was estimated by comparing the clinical disease activity after 3 years with the K7 expression at the time of enrollment. Our data shows that the level of K7 expression in inflamed epithelium varies depending on the anatomical region and it is the most pronounced in ascending and descending colon, but it did not predict the severity of IBD for the following 3 years. These results warrant future studies focusing on the biological role of K7 in colon and its utilization as potential IBD biomarker.

Colonocyte keratin 7 is expressed de novo in inflammatory bowel diseases and associated with pathological changes and drug-resistance.

The clinical course of IBD, characterized by relapses and remissions, is difficult to predict. Initial diagnosis can be challenging, and novel disease markers are needed. Keratin 7 (K7) is a cytoskeletal intermediate filament protein not expressed in the colonic epithelium but has been reported in IBD-associated colorectal tumors. Our aim was to analyze whether K7 is expressed in chronic colonic inflammatory diseases and evaluate its potential as a novel biomarker. K7 was analyzed in two patient cohorts using immunohistochemistry-stained colon samples and single-cell quantitative digital pathology methods. K7 was correlated to pathological changes and clinical patient characteristics. Our data shows that K7 is expressed de novo in the colonic epithelium of ulcerative colitis and Crohn's disease IBD patients, but not in collagenous or lymphocytic colitis. K7 mRNA expression was significantly increased in colons of IBD patients compared to controls when assessed in publicly available datasets. While K7 increased in areas with inflammatory activity, it was not expressed in specific crypt compartments and did not correlate with neutrophils or stool calprotectin. K7 was increased in areas proximal to pathological alterations and was most pronounced in drug-resistant ulcerative colitis. In conclusion, colonic epithelial K7 is neo-expressed selectively in IBD patients and could be investigated for its potential as a disease biomarker.

Therapeutic management and outcomes in inflammatory bowel diseases, 2010 to 2017 in cohorts from Denmark, Sweden and Norway.

BACKGROUND: Despite the increasing use of biologics in patients with inflammatory bowel disease (IBD), real-world data about outcomes in the era of biologics remain inconclusive. AIMS: To investigate trends in surgeries, hospitalisations and medication use in patients with IBD in a multinational, population-based cohort METHODS: We included 42,894 patients with ulcerative colitis (UC) and 24,864 with Crohn's disease (CD) who were diagnosed between 2010 and 2017 in Denmark, Norway and Sweden. We extracted data about surgeries, hospitalisations and medications from national registries and compared across countries and diagnosis years. RESULTS: Between 2010 and 2017, 2-year surgery rates were 4-7% in UC and 10-15% in CD and were stable over time. Two-year hospitalisation rates increased in Denmark (UC: 20% to 35%; CD: 27% to 32%) but were stable in Norway and Sweden (fluctuating between 33% and 37% in UC, and 46% and 52% in CD). Two-year rates of biologic use increased in both UC (7% to 16% in Denmark, 8% to 18% in Norway) and CD (22% to 26% in Denmark; 21% to 35% in Norway). Two-year rates of immunomodulator use increased in Norway (from 14% to 23% in UC; 37% to 45% in CD) and Sweden (from 41% to 52% in CD), but were stable in Denmark (between 17% and 21% in UC; 39% to 46% in CD). CONCLUSION: Between 2010 and 2017, surgery rates among Scandinavian patients with IBD remained stable, with no clear changes in hospitalisation rates despite the increasing use of immunomodulators and biologics.

Direct costs of inflammatory bowel diseases in a Finnish tertiary-level clinic.

Background: Inflammatory bowel disease (IBD), Crohn's disease (CD) and ulcerative colitis (UC) are chronic diseases associated with a high and continuous economic burden. The introduction of biologics has changed the distribution of costs over the past two decades, and there are no recent studies on direct costs in Finland. This study aimed to estimate the direct healthcare costs of these diseases in a tertiary-level clinic. Methods: The data were collected during a 1-year period of patients with IBD visiting Turku University Hospital. Patients were included if they lived in the hospital district area and were over 18 years old. This comprised an IBD group of 2208 patients, including 794 cases of CD and 1414 cases of UC. A sex-matched and age-matched control group was collected for comparison. Direct costs were collected during a 1-year study period from the hospital records. Results: Total direct costs per patient with IBD in a tertiary-level clinic were €4223 annually. IBD-generated direct costs were estimated to total €3981 per patient annually. Patients with IBD who were given infliximab had €9157 higher direct healthcare costs per patient annually than patients with IBD with no infliximab medication. Direct healthcare costs generated in a tertiary-level gastroenterological clinic averaged €1652 per patient with IBD annually. On average, patients with CD had €1111 higher direct healthcare costs annually than patients with UC. Conclusions: The direct healthcare costs of IBD were significant, almost 17-fold higher compared with a control group. Patients with IBD administered with biologics had significantly higher costs. Patients with CD had higher annual infliximab costs than patients with UC.

Piloting gender-oriented colorectal cancer screening with a faecal immunochemical test: population-based registry study from Finland.

OBJECTIVE: To assess the feasibility and evaluate the performance of a relaunched colorectal cancer (CRC) screening programme with different cut-offs for men and women. DESIGN: Population-based registry study. SETTING: Nine municipalities in Finland which started CRC screening with faecal immunochemical test (FIT) in April 2019 with cut-off levels 70 µg Hg/g faeces for men and 25 µg Hg/g faeces for women. PARTICIPANTS: Men (n=13 059) and women (n=14 669) aged 60-66 years invited to screening during the first programme year. OUTCOME MEASURES: Participation rates, positivity rates, detection rates of CRC and advanced adenoma (AA), and positive predictive values (PPV) of FIT for CRC and AA. RESULTS: Altogether 21 993 invitees returned stool samples. The participation rate of women (83.4%; 95% CI 82.8 to 84.0) was significantly higher than that of men (74.7%; 95% CI 73.9 to 75.4). The positivity rates were 2.4% (2.2 to 2.7) and 2.8% (2.5 to 3.1), respectively. In total, 37 CRCs and 116 AAs were detected. The detection rates of CRC and AA per 1000 participants were 1.8 (1.1 to 2.9) and 7.2 (5.6 to 9.1) for men and 1.6 (0.9 to 2.4) and 3.8 (2.8 to 5.0) for women. The PPVs per 100 positive tests were 6.6 (4.0 to 10.3) and 25.7 (20.6 to 31.4) for men and 6.4 (3.9 to 9.8) and 15.5 (11.6 to 20.2) for women. CONCLUSIONS: The chosen FIT strategy narrowed the gap in the diagnostic performance between men and women especially in the detection of CRC. The participation rates were excellent. The levels of positivity and detection rates were moderate and need further action. The results indicate that gender-specific protocols can be introduced to organised CRC screening. It is yet to be seen whether they are more effective than a uniform screening protocol.

[Esophagoscopic monitoring of Barrett's esophagus--additional life years of good quality or wasting of limited resources?]. / Barrettin ruokatorven tähystysseuranta.

More than 90% of patients with cancers of the esophagus will succumb to these diseases. Adenocarcinoma of the esophagus has rapidly become more common in the western countries and its occurrence already exceeds that of squamous cell carcinoma in many countries. Monitoring of Barrett patients is recommended, since Barrett's esophagus is the most important risk factor for adenocarcinoma. Scientific evidence of the effectiveness of monitoring is, however, scarce. It would be more correct to speak about monitoring of adenocarcinoma instead of Barrett's esophagus, because the aim is reduction of cancer mortality by screening.

Effect of smoking on gastric histology in Helicobacter pylori-positive gastritis.

OBJECTIVE: Smoking and Helicobacter pylori are both deleterious to the gastric and duodenal mucosa. Smoking also seems to modify inflammation in H. pylori infection. The aim of this study was to investigate the relationship between smoking and H. pylori in the Finnish population. MATERIAL AND METHODS: We analysed the effect of smoking on gastric inflammation, humoral response to H. pylori and peptic ulcer disease among 318 Finnish H. pylori-positive patients (age 18-75 years; 73 smokers). Gastric histology was evaluated according to the updated Sydney system. RESULTS: Smoking affected neither antral inflammation nor atrophy. In the gastric body, smokers showed milder chronic and neutrophilic inflammation and less atrophy (4% versus 17%, p=0.004). In smokers, H. pylori infiltration was denser in the atrium (mean 2.14 versus 1.87, p=0.02) but less dense in the body (mean 1.55 versus 1.84, p=0.003). Smoking thus seems to decrease inflammation in the gastric body and to delay atrophic changes in the gastric body. Subsequently, the prevalence of duodenal ulcers increased (32% versus 11%, p<0.001), but not the prevalence of gastric ulcers. Smoking also reduced serum IgG antibody titres against H. pylori (mean 8535 versus 5587, p=0.002) and their percentage decrease after successful eradication, possibly affecting serological diagnostic efficacy. Smokers were younger than non-smokers, but when age was taken into account, the differences remained the same. CONCLUSIONS: In H. pylori-positive gastritis, smoking reduced inflammation and atrophy in the gastric body as well as humoral response to H. pylori.

Symptoms, endoscopic findings and histology predicting symptomatic benefit of Helicobacter pylori eradication.

OBJECTIVE: To analyse factors predicting changes in dyspeptic symptoms after Helicobacter pylori eradication. MATERIAL AND METHODS: Of a total of 342 patients referred for upper gastrointestinal endoscopy at 23 centres in various parts of Finland, those tested positive for the rapid urease test were recruited in the study. Clinical and demographic data and data on dyspeptic symptoms (Gastrointestinal Symptoms Rating Scale) were collected via a structured questionnaire before and a year after the eradication therapy. Gastric biopsies were analysed according to the updated Sydney system. RESULTS: A total of 216 H. pylori-positive patients treated successfully with eradication therapy had complete data to be analysed. After the therapy, dyspeptic symptoms decreased by 29-32%. In a univariate analysis, it was found that duodenal ulcer, female gender, gastric antral neutrophilic inflammation, smoking and age from 50 to 59 years enhanced symptom improvement whereas atrophy in the gastric body reduced it. In a multivariate analysis, duodenal ulcer (odds ratio (OR) 3.2, 95% CI 1.3-7.8) and age from 50 to 59 years (OR 2.2; 95% CI 1.2-3.9) and antral neutrophilic inflammation (OR 1.9, 95% CI 1.1-3.3) were better predictors of symptomatic response. CONCLUSION: The symptomatic benefit from H. pylori eradication therapy was greatest among duodenal ulcer patients.

Low childhood high density lipoprotein cholesterol levels and subsequent risk for chronic inflammatory bowel disease.

BACKGROUND AND AIMS: Several genetic and environmental risk factors have been linked to chronic inflammatory bowel disease (IBD). The incidence of IBD has significantly increased in developed countries during last decades. The aim of the present study was to examine childhood risk factors for subsequent IBD diagnosis in a longitudinal cohort study of children and adolescents. METHODS: A Finnish study population consisting of 3551 children and adolescents originally evaluated as part of the Cardiovascular Risk in Young Finns study in 1980. At baseline, participant BMI, insulin, lipid, C-reactive protein and blood pressure levels, socioeconomic position, dietary habits, and physical activity, were evaluated. In addition, information was gathered on rural residency, severe infections, breast feeding, parental smoking and birth weight. Subsequent IBD diagnosis status was evaluated based on nationwide registries on hospitalisations and drug imbursement decisions. RESULTS: Altogether, 49 participants (1.4%) had IBD diagnosed during the 34 years of register follow-up, of which 31 had ulcerative colitis, 12 Crohn's disease and 6 undetermined colitis. In univariate analyses, significant correlations were observed between childhood HDL-cholesterol (risk ratio (95% CI) for 1-SD change (0.58 (0.42-0.79)) and CRP concentrations (1.20 (1.01-1.43)) with IBD. The inverse association between HDL-cholesterol and IBD remained significant (0.57 (0.39-0.82)) in a multivariable model including data on age, sex and CRP. In addition, a weighted genetic z-score of 71 single nucleotide polymorphisms associated with elevated HDL-cholesterol levels was significantly lower in IBD patients, P=0.01). CONCLUSION: Low childhood HDL-cholesterol levels are associated with subsequent IBD diagnosis. In addition, a genetic risk score associated with low HDL-cholesterol levels predict later IBD suggesting that HDL-cholesterol metabolism might have a role in the pathogenesis of IBD.

Evaluation of the diagnostic accuracy of gastroscopy to detect gastric tumours: clinicopathological features and prognosis of patients with gastric cancer missed on endoscopy.

OBJECTIVES: Some gastric cancers are missed during diagnostic gastroscopy, but data are sparse on the clinical characteristics of patients with missed gastric cancers and on the accuracy of gastroscopy for detecting these tumours. We evaluated the number, clinicopathological characteristics, and survival of patients with missed gastric cancers, and the sensitivity and specificity of gastroscopy to detect these tumours. METHODS: Data on gastric cancers detected in 1996-2001 in a single hospital referral area were obtained from the National Cancer Registry. Patient files were examined to identify those who underwent gastroscopy less than 3.5 years before a cancer diagnosis. RESULTS: Of the 284 gastric cancer patients, 13 (4.6%) had undergone gastroscopy in the previous 3.5 years; their mean age was 72.4 years at the time of the first gastroscopy. The median delay in cancer diagnosis was 11.5 months. Histologically, all patients had gastric carcinoma. The sensitivity and specificity of gastroscopy for diagnosing gastric cancer were 0.93 and 1.00, respectively. Among the deceased patients, no difference was observed in the survival of cases with non-missed (n = 191) and missed (n = 10) carcinoma: 9.4 versus 7.3 months (P = 0.15). CONCLUSION: A small proportion of gastric carcinomas are missed on gastroscopy, causing a significant delay in diagnosis. However, the prognoses of patients with missed and non-missed gastric carcinoma were equally poor.

Quality of life following laparoscopic Nissen fundoplication: assessing short-term and long-term outcomes.

AIM: To investigate the quality of life following laparoscopic Nissen fundoplication by assessing short-term and long-term outcomes. METHODS: From 1992 to 2005, 249 patients underwent laparoscopic Nissen fundoplication. Short-term outcome data including symptom response, side effects of surgery, endoscopy, and patient's perception of overall success were collected prospectively. Long-term outcomes were investigated retrospectively in patients with a median follow-up of 10 years by assessment of reflux symptoms, side effects of surgery, durability of antireflux surgery, need for additional treatment, patient's perception of success, and quality of life. Antireflux surgery was considered a failure based on the following criteria: moderate to severe heartburn or regurgitation; moderate to severe dysphagia reported in combination with heartburn or regurgitation; regular proton pump inhibitor medication use; endoscopic evidence of erosive esophagitis Savary-Miller grade 1-4; pathological 24-h pH monitoring; or necessity to undergo an additional surgery. The main outcome measures were short- and long-term cure rates and quality of life, with patient satisfaction as a secondary outcome measure. RESULTS: Conversion from laparoscopy to open surgery was necessary in 2.4% of patients. Mortality was zero and the 30-d morbidity was 7.6% (95%CI: 4.7%-11.7%). The median postoperative hospital stay was 2 d [interquartile range (IQR) 2-3 d]. Two hundred and forty-seven patients were interviewed for short-term analysis following endoscopy. Gastroesophageal reflux disease was cured in 98.4% (95%CI: 95.9%-99.6%) of patients three months after surgery. New-onset dysphagia was encountered postoperatively in 13 patients (6.7%); 95% reported that the outcome was better after antireflux surgery than with preoperative medical treatment. One hundred and thirty-nine patients with a median follow-up of 10.2 years (IQR 7.2-11.6 years) were available for a long-term evaluation. Cumulative long-term cure rates were 87.7% (81.0%-92.2%) at 5 years and 72.9% (64.0%-79.9%) at 10 years. Gastrointestinal symptom rating scores and RAND-36 quality of life scores of patients with treatment success were similar to those of the general population but significantly lower in those with failed antireflux surgery. Of the patients available for long-term follow-up, 83% rated their operation a success. CONCLUSION: For the long-term, our results indicate decreasing effectiveness of laparoscopic antireflux surgery, although most of the patients seem to have an overall quality of life similar to that of the general population.