Inflammatory bowel disease in South-Eastern Norway III (IBSEN III): a new population-based inception cohort study from South-Eastern Norway.

BACKGROUND AND AIM: Modern treatment strategies for inflammatory bowel disease (IBD) are postulated to change the natural disease course. Inception cohort studies are the gold standard for investigating such changes. We have initiated a new population-based inception cohort study; Inflammatory bowel disease in South Eastern Norway III (IBSEN III). In this article, we describe the study protocol and baseline characteristics of the cohort. METHODS: IBSEN III is an ongoing, population-based observational inception cohort study with prospective follow-up. Adult and pediatric patients with suspected IBD in the South-Eastern Health Region of Norway (catchment area of 2.95 million inhabitants in 2017), during the 3-year period from 2017 to 2019, were eligible for inclusion. Comprehensive clinical, biochemical, endoscopic, demographic, and patient-reported data were collected at the time of diagnosis and throughout standardized follow-up. For a portion of the patients, extensive biological material was biobanked. RESULTS: The study included 2168 patients, of whom 1779 were diagnosed with IBD (Crohn's disease: 626, ulcerative colitis: 1082, IBD unclassified: 71). In 124 patients, there were subtle findings indicative of, but not diagnostic for, IBD. The remaining 265 patients were classified as symptomatic non-IBD controls. CONCLUSION: We have included patients in a comprehensive population-based IBD cohort from a catchment population of 2.95 million, and a unique biobank with materials from newly diagnosed and treatment-naïve IBD patients and symptomatic non-IBD controls. We believe this cohort will add important knowledge about IBD in the years to come.

Prevalence of Sclerosing Cholangitis Detected by Magnetic Resonance Cholangiography in Patients With Long-term Inflammatory Bowel Disease.

BACKGROUND & AIMS: The prevalence of primary sclerosing cholangitis (PSC) among patients with inflammatory bowel disease (IBD) is unclear. Patients with IBD might be screened for PSC using magnetic resonance cholangiography (MRC). We aimed to estimate the frequency and distribution of MRC-detected lesions that indicate PSC in patients with IBD 20 years after their initial diagnosis and to identify clinical characteristics associated with these findings. METHODS: We performed a follow-up analysis of a population-based cohort of 756 patients in South-Eastern Norway diagnosed with IBD from January 1, 1990 through December 31, 1993. Of these subjects, 470 attended a follow-up evaluation 20 years later in which they were offered routine clinical blood testing and ileocolonoscopy; 322 were screened by MRC (222 with ulcerative colitis and 100 with Crohn's disease). Two radiologists independently evaluated results from the MRC examinations. RESULTS: In the MRC examination, 24 patients (7.5%) were found to have PSC-like lesions; only 7 of these patients (2.2%) were known to have PSC. One patient was initially missed and 1 had small-duct PSC, so the final prevalence of PSC was 8.1%. Extensive colitis, a high prevalence of colectomy, and chronic and continuous symptoms of IBD occurred in significantly more patients with suspected PSC than without PSC (P = .029, P = .002, and P = .012, respectively). Among patients with subclinical features of PSC, the MRC progression score for PSC increased when they were re-examined after a median 3.2 years (P = .046). CONCLUSIONS: Using MRC analysis of patients with long-term IBD, we found the prevalence of PSC to be around 3-fold higher than that detected based on symptoms. Sixty-five percent of patients had subclinical PSC associated with progressive IBD, with no biochemical abnormalities and mild disease, based on radiology findings. PSC appears to progress in patients with subclinical disease, but long-term outcomes are not known.

Patient-reported adverse events after colonoscopy in Norway.

Background and aims Patient-reported outcome measures are increasingly important in healthcare. European guidelines have recommended inclusion of patient feedback to capture adverse events due to colonoscopy, but this is rarely implemented. Methods The Norwegian Quality Assurance network for endoscopy (Gastronet) collects patient-reported outcome for colonoscopies. Free-text comments on patient reports from January to December 2015 were characterized as positive or negative. All negative free-text comments were scrutinized for information that might suggest colonoscopy-related adverse events. We identified severe adverse events with and without admission to hospital. Results We included 16 552 outpatient colonoscopies performed at 21 hospitals. A total of 11 248 procedures (68 %) were accompanied by a patient feedback report, of which 2628 (23 %) had free-text comments (2196 [20 %] characterized as positive and 432 [3.8 %] as negative). These negative free texts on patient reports revealed 15 post-colonoscopy hospital admissions due to adverse events that had not been registered in the colonoscopy report. This increased the number of hospital admissions caused by adverse events from 3 (0.03 %) to 18 (0.16 %). In addition, there were 14 patient reports of severe events without hospital admission. Therefore, a total of 29 severe adverse events reported by patients were missed by conventional documentation in the colonoscopy form. Conclusion It is feasible to implement patient feedback as routine reporting to capture the full picture of colonoscopy-related adverse events. Some patients experience significant complications that are not recorded through any registries. Patient feedback forms should be tailored to capture adverse events after colonoscopy that are otherwise not easily disclosed.

Fatigue in a population-based cohort of patients with inflammatory bowel disease 20 years after diagnosis: The IBSEN study.

OBJECTIVE: Fatigue is a major concern for patients with ulcerative colitis (UC) and Crohn's disease (CD), but evidence from population-based studies regarding fatigue in long-standing inflammatory bowel disease (IBD) patients is scarce. Our aims were to assess fatigue scores and the prevalence of chronic fatigue in IBD patients 20 years after diagnosis and to identify variables associated with fatigue in this cohort. METHODS: Twenty years after diagnosis, patients from a cohort with incident IBD were invited to a follow-up visit that included a structured interview, a clinical examination, laboratory tests and the Fatigue Questionnaire (FQ). Fatigue scores were obtained, and factors associated with fatigue were assessed via linear and logistic regression analyses. RESULTS: Of the 599 invited patients, 440 (73.5%) completed the FQ. Among those with active disease, we found significantly higher fatigue scores than among those with quiescent disease (fatigue scores: UC 17.1 versus 12.4, p < .001, and CD 17.5 versus 13.3, p < .001). The fatigue scores of those with quiescent disease were comparable with those of the reference population. Chronic fatigue was more frequent among IBD patients than in the reference population. Factors associated with fatigue included self-perceived disease activity, poor sleep quality, anxiety and depression. CONCLUSION: At 20 years after IBD diagnosis, fatigue scores were higher and chronic fatigue was more frequent among IBD patients with active disease than in the reference population and among those with quiescent IBD. Subjectively perceived disease activity, sleep quality, anxiety and depression were associated with fatigue in IBD patients.

Long-term mucosal recovery and healing in celiac disease is the rule - not the exception.

OBJECTIVE: The prevalence of persistent villous atrophy (VA) in patients with celiac disease (CD) on a gluten-free diet (GFD) varies greatly between studies. Most studies show a relatively high prevalence of mucosal atrophy and inflammation in treated patients, a finding which have led to a concept of non-responsive CD. Few studies have examined the prevalence of long-term mucosal healing. Our study aimed to determine the extent of mucosal healing in a cohort of Norwegian patients with CD treated with GFD for several years. MATERIALS AND METHODS: Adult patients diagnosed with VA between 1989 and 2009 were included. We performed a follow-up gastroscopy with duodenal biopsies. Two pathologists evaluated the biopsies according to the Marsh-Oberhuber classification. Mucosal healing was defined as Marsh 0 while mucosal recovery was defined as Marsh 0-2. RESULTS: Duodenal biopsies were obtained from 127 adult patients with established CD. After a follow-up time of 8.1 years (median, range 2.3-22.3), 103 (81%) of the patients showed mucosal healing, 120 patients (94%) showed mucosal recovery, and 7 patients (6%) showed persistent VA. In addition, 103 of the 127 patients (81%) had undergone a routine follow-up biopsy 12.6 months (median, range 5.2-28.8) after diagnosis. At the time of the routine follow-up, only 52 of these patients (50.5%) had achieved mucosal recovery. CONCLUSIONS: Although half of the patients had persistent VA at the time of routine follow-up, both long-term mucosal recovery and healing is possible for the vast majority of adult patients with CD.

Extraintestinal manifestations in Crohn's disease and ulcerative colitis: results from a prospective, population-based European inception cohort.

BACKGROUND: In chronic inflammatory bowel disease (IBD) (Crohn's disease [CD] and ulcerative colitis [UC]), symptoms from outside the gastrointestinal tract are frequently seen, and the joints, skin, eyes, and hepatobiliary area are the most usually affected sites (called extraintestinal manifestations [EIM]). The reported prevalence varies, explained by difference in study design and populations under investigation. The aim of our study was to determine the prevalence of EIM in a population-based inception cohort in Europe and Israel. METHODS: IBD patients were incepted into a cohort that was prospectively followed from 1991 to 2004. A total of 1145 patients were followed for 10 years. RESULTS: The cumulative prevalence of first EIM was 16.9% (193/1145 patients) over a median follow-up time of 10.1 years. Patients with CD were more likely than UC patients to have immune-mediated (arthritis, eye, skin, and liver) manifestations: 20.1% versus 10.4% (p < 0.001). Most frequently seen was arthritis which was significantly more common in CD (12.9%) than in UC (8.1%), p = 0.01. Pan-colitis compared to proctitis in UC increased the risk of EIM. CONCLUSION: In a European inception cohort, EIMs in IBD were consistent with that seen in comparable studies. Patients with CD are twice as likely as UC patients to experience EIM, and more extensive distribution of inflammation in UC increases the risk of EIM.

Thromboembolism in inflammatory bowel disease: results from a prospective, population-based European inception cohort.

BACKGROUND: Patients with inflammatory bowel disease (IBD) have proven an increased risk of venous thromboembolism (VTE), particularly when hospitalized. The estimate of the true risk varies considerably between studies, primarily due to differences in methodology. We set out to determine the incidence of VTE in a population-based European inception cohort. METHODS: IBD patients were incepted into a cohort that was prospectively followed from the early 1990s to the early 2000s. A total of 1145 patients were followed for a total of 10,634 patient-years (p.y.). RESULTS: A total of 19 thromboembolic events were identified - 13 deep vein thrombosis and 6 with pulmonary embolism. The incidence rate of VTE was 1.8 per 1000 p.y. CONCLUSION: The risk of VTE was elevated in this IBD cohort but lower than previously reported. The highest risk was seen in hospitalized patients, but corticosteroids-requiring disease in outpatients also conferred some risk.

Clinical course of ulcerative colitis: Frequent use of biologics and low colectomy rate first year after diagnosis-results from the IBSEN III inception cohort.

BACKGROUND: The introduction of biologic therapies and the 'treat-to-target' treatment strategy may have changed the disease course of ulcerative colitis (UC). AIMS: To describe the early disease course and disease outcome at 1-year follow-up in a population-based inception cohort of adult patients with newly diagnosed UC. METHODS: The Inflammatory Bowel Disease in South-Eastern Norway (IBSEN) III study is a population-based inception cohort study with prospective follow-up. Patients newly diagnosed with inflammatory bowel disease during 2017-2019 were included. Patients ≥18 years at diagnosis of UC who attended the 1-year follow-up were investigated. We registered clinical, endoscopic and demographic data at diagnosis and 1-year follow-up. RESULTS: We included 877 patients with UC (median age 36 years (range: 18-84), 45.8% female). At diagnosis, 39.2% presented with proctitis, 24.7% left-sided colitis and 36.0% extensive colitis. At the 1-year follow-up, 13.9% experienced disease progression, and 14.5% had received one or more biologic therapies. The colectomy rate was 0.9%. Steroid-free clinical remission was observed in 76.6%, and steroid-free endoscopic remission in 68.7%. Anaemia and initiation of systemic steroid treatment at diagnosis were associated with biologic therapy within the first year after diagnosis. CONCLUSION: In this population-based inception cohort, colectomy rate in the first year after diagnosis was low, and a high proportion of patients were in remission at 1-year follow-up. The use of biologic therapy increases, consistent with findings from previous studies.

Risk stratification to predict pain during unsedated colonoscopy: results of a multicenter cohort study.

BACKGROUND AND STUDY AIMS: Colonoscopy without sedation has several advantages over sedated colonoscopy, but a considerable proportion of patients experience pain. The aim of this study was to develop a risk stratification model of pre-examination risk factors to enable targeted sedation during colonoscopy. PATIENTS AND METHODS: Between October 2011 and January 2012, consecutive outpatients who were willing to start colonoscopy without sedation at 11 Norwegian centers were prospectively recruited. Patients recorded pain on a validated 4-point scale (none, slight, moderate, or severe pain). Potential risk factors for a painful procedure (defined as moderate or severe pain) were evaluated using multivariate logistic regression analyses, and the area under the receiver operating characteristics curve (AUROC) was calculated to assess the discriminatory ability of the derived model. RESULTS: A total of 1198 patients (635 men and 563 women) were included. Seven independent, pre-procedural risk factors for patient pain were identified: female sex, age < 40 years, previous abdominal surgery, abdominal pain as indication for colonoscopy, anticipation of pain, previous painful colonoscopy, and a history of diverticulitis. In patients with 0, 1, 2, or ≥ 3 risk factors, a painful colonoscopy was experienced by 35 %, 43 %, 52 %, and 63 % of women and 18 %, 24 %, 35 %, and 63 % of men, respectively. The model showed modest discrimination abilities (AUROC = 0.69). CONCLUSION: Female sex was a strong risk factor for pain during colonoscopy, and sedation or analgesia should be considered for all women prior to colonoscopy. For male patients, the presence of multiple risk factors should encourage the endoscopist to offer sedation.

[Pain in connection with colonoscopy in Norway]. / Smerter ved koloskopi.

BACKGROUND: Colonoscopies are common examinations at Norwegian hospitals. In contrast to many other countries, the majority of colonoscopies in Norway are conducted without routine sedation or analgesia. We wanted to investigate whether current Norwegian practice offers adequate pain relief. MATERIAL AND METHOD: The material consists of prospectively recorded outpatient colonoscopies in the period January 2003-December 2011 performed at Norwegian hospitals in the quality assurance network for gastrointestinal endoscopy (Gastronet). We analysed demographic patient data and data from colonoscopies. Patients' experience of pain (none, slight, moderate or severe pain) in connection with the examination was established with the aid of a validated questionnaire. RESULTS: Data from 61,749 colonoscopies (55% on women) performed at 29 different hospitals were analysed. Colonoscopies were perceived as moderately or very painful by 33% of the patients (41% of the women, 24% of the men, p < 0.001). There were substantial differences between hospitals as to the percentage of colonoscopies that were perceived as moderately or very painful (from 9% to 43%, p < 0.001) and the use of sedatives and analgesics for the colonoscopies (from 1% to 92% of the examinations, p < 0.001). Only 23% of those who found the colonoscopy painful received analgesics. Pethidine was used in 95% of the cases in which analgesics were used during the examination. INTERPRETATION: Many patients find colonoscopies painful. Pain relief practice varies substantially between hospitals. Pethidine is an analgesic with a slow onset of action, and should perhaps be replaced with more rapidly acting opiates.

Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial.

BACKGROUND: Knowing the position of the endoscope within the abdomen is important for performing a high-quality, painless colonoscopy. The recently introduced magnetic endoscopic imaging (MEI) system provides a continuous, real-time image of the endoscope during the entire procedure. OBJECTIVE: To compare MEI versus standard colonoscopy with on-demand fluoroscopy on unsedated patients, as performed by experienced and inexperienced endoscopists. DESIGN: Randomized, controlled trial. SETTING: Endoscopy outpatient clinic. PATIENTS: This study involved 810 consecutive patients (391 randomized to standard group; 419 randomized to MEI) referred for colonoscopy. INTERVENTION: MEI or standard approach (involving on-demand fluoroscopy) during colonoscopy. MAIN OUTCOME MEASUREMENTS: Perceived patient pain and cecal intubation rate and time to cecum. RESULTS: For inexperienced endoscopists, the cecal intubation rate was significantly higher in the MEI group (77.8%) compared with the standard group (56.0%), P = .02 but not for experienced endoscopists (94.0% for MEI and 96.0% for standard group, P = .87). Inexperienced endoscopists had less need for assistance from a senior colleague when they used MEI (18.5%) compared with the standard technique (40.0%), P = .02. Mean (± standard deviation) time to reach the cecum was 14.0 ± 12.2 minutes in the MEI group and 15.3 ± 14.2 minutes in the standard group, P = .67. LIMITATIONS: Single center, unblinded study. CONCLUSION: Inexperienced endoscopists improved their colonoscopy performance when they used MEI, compared with the standard technique, but experienced endoscopists did not. The MEI may be advantageous to use for colonoscopy centers educating endoscopists. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00519129.).

Evaluation of disease activity in IBD at the time of diagnosis by the use of clinical, biochemical, and fecal markers.

OBJECTIVE: The present population based adult cohort was part of a new prospective study of patients with inflammatory bowel disease (IBD) in South-Eastern Norway, the Inflammatory Bowel South-Eastern Norway II study, investigating disease characteristics in an attempt to improve our knowledge regarding factors related to early clinical phenotype and disease activity. MATERIAL AND METHODS: Patients suspected to have IBD on the basis of predefined symptoms, including abdominal pain, diarrhea, and/or blood in stool for more than 10 days were examined at the local hospital. Colonoscopy with biopsies was performed and blood and stool samples were taken. RESULTS: In ulcerative colitis (UC) patients, the median Simple Clinical Colitis Activity Index (SCCAI) was 4 (range 0-10) in mild and 6 (range 0-14) in patients with moderate or severe endoscopic activity of inflammation (p = 0.002). The calprotectin concentration in feces was significantly related to the SCCAI (p = 0.034) and the Mayo endoscopic subscore (p = 0.031). There was a significant association between the C-reactive protein (CRP) value, leucocytes and thrombocytes and the SCCAI, but only leucocytes were significantly associated with the Mayo endoscopic subscore. In Crohn's disease (CD) patients, there was no statistical significant association between the Harvey-Bradshaw Index (HBI) and the endoscopic grade of mucosal inflammation (p = 0.8). The calprotectin concentration in feces was significantly related to the endoscopic activity score (p = 0.004), but not to the HBI (p = 0.5). HBI was significantly related to the CRP value (p = 0.047) and thrombocytes (p = 0.03). CONCLUSIONS: In UC, both biochemical and fecal markers are related to disease activity and extent of disease, whereas in CD, the fecal calprotectin concentration is a reliable marker of mucosal affection, but not for systemic disease activity.

Gastronet survey on the use of one- or two-person technique for colonoscopy insertion.

BACKGROUND: Usually, colonoscopy insertion is performed by the colonoscopist (one-person technique). Quite common in the early days of endoscopy, the assisting nurse is now only rarely doing the insertion (two-person technique). Using the Norwegian national endoscopy quality assurance (QA) programme, Gastronet, we wanted to explore the extent of two-person technique practice and look into possible differences in performance and QA output measures. METHODS: 100 colonoscopists in 18 colonoscopy centres having reported their colonoscopies to Gastronet between January and December 2009 were asked if they practiced one- or two-person technique during insertion of the colonoscope. They were categorized accordingly for comparative analyses of QA indicators. RESULTS: 75 endoscopists responded to the survey (representing 9368 colonoscopies) - 62 of them (83%) applied one-person technique and 13 (17%) two-person technique. Patients age and sex distributions and indications for colonoscopy were also similar in the two groups. Caecal intubation was 96% in the two-person group compared to 92% in the one-person group (p < 0.001). Pain reports were similar in the groups, but time to the caecum was shorter and the use of sedation less in the two-person group. CONCLUSION: Two-person technique for colonoscope insertion was practiced by a considerable minority of endoscopists (17%). QA indicators were either similar to or better than one-person technique. This suggests that there may be some beneficial elements to this technique worth exploring and try to import into the much preferred one-person insertion technique.

Outcome of Ulcerative Colitis 20 Years after Diagnosis in a Prospective Population-based Inception Cohort from South-Eastern Norway, the IBSEN Study.

BACKGROUND AND AIMS: The long-term course of ulcerative colitis [UC] is difficult to predict. Mortality, colectomy, cancer, and hospitalisation represent hard outcomes of disease. Moreover, knowledge on the risk of relapses and need for potent medication add important information about living with UC. We aimed to evaluate the course and prognosis of UC during the first 20 years after diagnosis, and to identify early prognostic risk factors. METHODS: From 1990 to 1994, a population-based inception cohort of patients with inflammatory bowel disease was enrolled in South-Eastern Norway. A systematic follow-up [FU] was conducted at 1,5, 10, and 20 years after diagnosis. Clinical outcomes were recorded continuously, and possible relationships between early disease characteristics and outcomes were analysed using multiple regression analysis. RESULTS: Among 519 UC patients, 119 died, 60 were lost to FU, and 340 were included in the FU cohort. The 20-year cumulative risk of colectomy was 13.0% (95% confidence interval [CI] [11.4-14.6]). Extensive colitis at diagnosis was independently associated with an increased risk of colectomy compared with proctitis (hazard ratio [HR] = 2].8, 95% CI [1.3-6.1]). In contrast, mucosal healing at 1-year FU was independently associated with reduced risk of colectomy [HR = 0.4, 95% CI [0.2-0.8]), and inversely associated with subsequent risk of relapse [adjusted HR = 0.5, 95% CI [0.3-0.7]). CONCLUSIONS: The overall risk of colectomy in our cohort was lower than expected from previous studies, although considerable for patients with extensive colitis at diagnosis. Early mucosal healing was associated with better disease outcomes 20 years after diagnosis.

Sustaining the vitality of colonoscopy quality improvement programmes over time. Experience from the Norwegian Gastronet programme.

OBJECTIVE: An important challenge of any quality assurance (QA) programme is to maintain interest among participants to ensure high data quality over time. The primary aim of this study was to identify factors associated with endoscopist compliance with the Norwegian QA programme for colonoscopies (Gastronet). MATERIAL AND METHODS: The Gastronet registration tools are an endoscopy report form to be filled in directly after the procedure by the endoscopist, and a satisfaction questionnaire to be filled in by the patient on the day after the examination. During the study period from 1 January 2004 to 31 December 2006, endoscopist compliance was measured by assessing patient report coverage, defined as the percentage of patient satisfaction questionnaires received by the Gastronet secretariat divided by the total number of colonoscopy reports registered by the individual endoscopists during the study period. Multivariate logistic regression models were applied to identify individual factors related to patient report coverage. RESULTS: Eighty-eight endoscopists from 10 hospitals contributed a total of 16,149 colonoscopies. Overall patient report coverage decreased from 87% in 2004 to 80% in 2006. A low patient report coverage was associated with time since the registrations started [odds ratio (OR) 0.98, 95% confidence interval (CI) 0.97-0.98; P < 0.001], use of sedation (OR 0.7, 95% CI 0.61-0.76; P < 0.001), and incomplete colonoscopy (OR 0.6, 95% CI 0.54-0.76; P < 0.001). CONCLUSIONS: Decreasing compliance with registration over time may compromise data quality and the validity of the results. Lower coverage of patient's reports (presumably for the most difficult examinations) may lead to erroneous conclusions regarding colonoscopy performance.

Risk of colorectal cancer in a population-based study 20 years after diagnosis of ulcerative colitis: results from the IBSEN study.

Objective: The association between ulcerative colitis (UC) and colorectal cancer (CRC) is widely accepted, although attenuated risk has been reported in recent years. Colonoscopic surveillance is recommended with intervals based on established clinical risk factors. Nevertheless, a significant number of patients develop interval cancers, indicating the need of improved individualised assessment. In the present study, we evaluated clinical risk factors associated with CRC during a prescheduled follow-up 20 years after diagnosis, the IBSEN study. Design: A population-based inception cohort of patients diagnosed with inflammatory bowel disease from 1 January 1990 until 31 December 1993, prospectively followed at 1, 5, 10 and 20 years after diagnosis. A total of 517 patients with UC were included; 264 (51 %) men; median age at inclusion 37.4 years (4-88). Results: The overall incidence of CRC was 1.6% (8/517) at a 20-year follow-up. The total lifetime risk of CRC prior to or after UC diagnosis was 2.3%. (12/517). Patients older than 70 years at diagnosis had a 15-fold higher risk of CRC compared with those diagnosed when younger than 40 years, with HR 15.68 (95% CI: 1.31 to 187.92). Neither sex, first-degree relative with CRC, extent of colitis nor primary sclerosing cholangitis affected the risk of CRC. Conclusion: The risk of CRC in UC was low and comparable with the risk of CRC in the background population of Norway.

Effect of oral lansoprazole on intragastric pH after endoscopic treatment for bleeding peptic ulcer.

OBJECTIVE: Intravenous proton pump inhibitors (PPIs) induce a high intragastric pH and may thereby improve haemostasis in patients with bleeding peptic ulcer. The aim of this study was to investigate whether a similar therapeutic intragastric pH level could be reached when the PPI was administered orally. MATERIAL AND METHODS: Twenty-four-hour intragastric pH was measured in patients treated endoscopically for bleeding peptic ulcer (Forrest class I or II). The patients received lansoprazole capsules (90 mg) after successful endoscopic treatment, followed by 30 mg every third hour for 72 h. The primary end-point was the percentage of the 0 to 24-h registration period with an intragastric pH of 6 or higher. Additionally, the total number of patients obtaining an intragastric pH above 6 for 80% or more of the 0 to 24-h period after start of treatment was evaluated. RESULTS: Of the 14 patients included in the study (4 F, mean age 74 years, range 50-84 years), 10 patients had duodenal ulcer and 4 had gastric ulcer; median lowest Hgb: 8.9 mg/ml (range 5.8-12.4), blood transfusions: 2.7 SAG units (range 0-7). In the 0 to 24-h period, the median time duration of pH above 6 was 55% (range 6-99). One out of 14 patients (7%) reached a pH above 6 in at least 80% of this time period. CONCLUSIONS: An increase in intragastric pH of therapeutic importance was reached with this oral medication regimen. However, there were large intra-individual differences. Treatment with oral lansoprazole may be a therapeutic alternative to intravenous administration of PPI.

Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study).

OBJECTIVE: Cohort studies of unselected and newly diagnosed patients are essential for a better understanding of the prognosis in ulcerative colitis (UC). The aim of this study was to evaluate the course of UC in a population-based inception cohort during the first 10 years, and to identify prognostic risk factors based on information gathered at diagnosis. MATERIAL AND METHODS: From 1990 to 1994, a population-based cohort of 843 patients with inflammatory bowel disease was enrolled in South-Eastern Norway. The cohort was systematically followed-up at 1, 5 and 10 years after diagnosis. RESULTS: Of 519 patients with UC, 423 completed the 10-year follow-up, 53 died and 43 were lost to follow-up. The mortality risk was not increased compared with that in the general population. The cumulative colectomy rate after 10 years was 9.8% (95% CI: 7.4-12.4%). Initial presentation with extensive colitis and erythrocyte sedimentation rate (ESR) > or =30 mm/h was associated with an increased hazard ratio (HR) (3.57, 95% CI: 1.60-7.96) and age > or =50 years at diagnosis, with reduced HR (0.28, 95% CI: 0.12-0.65) for subsequent colectomy. Relapsing disease was noted in 83%, but half (48%) of the patients were relapse free during the last 5 years. One-fifth (69/288) of patients with proctitis or left-sided colitis had progressed to extensive colitis. CONCLUSIONS: The prognosis for UC during the first 10 years was generally good. The colectomy rate was low, and a large proportion of patients were in remission as time progressed. Patients with initially extensive colitis and elevated ESR could benefit from an early potent medical treatment strategy.

No major reduction in bone mineral density after long-term treatment of patients with Celiac Disease.

BACKGROUND: At time of diagnosis, patients with celiac disease (CD) have been shown to have lower bone mineral density (BMD) than healthy controls. It is unclear whether adult patients with CD can regain a normal BMD after treatment with a gluten-free diet (GFD). METHODS: Patients diagnosed with CD as adults, who had been treated with GFD for a minimum of two years, were examined by dual energy X-ray absorptiometry (DXA) to determine BMD at femoral neck and spine L2-4. Adherence to GFD was measured using the Celiac Disease Adherence Test (CDAT) scoring tool. RESULTS: 143 CD patients underwent DXA assessment, mean age was 55.8 years and mean treatment duration was 9.3 years. 67% of the patients were women, and 51% of these were postmenopausal. The prevalence of low bone mass (Z-score ≤ -1.0) was 18.2% (95%CI: 12.7-25.3%) at femoral neck and 23.1% (95%CI: 16.9-30.6%) at spine L2-4. An increase in low bone density prevalence at spine L2-4 compared to the expected prevalence (p = 0.016) was limited to the postmenopausal women. In a multiple regression analysis, only postmenopausal status and poor adherence to GFD was independently associated with reduced bone density, this however limited to spine L2-4. CONCLUSION: Our study shows a small increase in the prevalence of low bone density at lumbar spine limited to the postmenopausal women. The main finding is that the majority of the CD patients after two years of treatment with GFD had a normal bone density when adjusted for age, gender, ethnicity and weight.

Registration bias in a clinical quality register.

Background and aims The quality of medical quality registers is poorly defined and lack of trust in data due to low completeness may be a major barrier against their use in quality improvement interventions. The aim of the current observational study was to explore how selective reporting may influence adverse events registered in the Norwegian quality register for colonoscopy (Gastronet). Materials and methods Gastronet's database includes data provided by endoscopists, nurses and patients. All outpatient colonoscopies reported to Gastronet in 2015 were included and compared to the total number of colonoscopies performed in Norway as retrieved from the National Patient Registry. Hospitals were categorized into four groups according to reporting completeness < 50 %, 50 % to 69 %, 70 % to 89 % and ≥ 90 %. The number of recorded adverse events (AEs) and procedure time were analyzed. Multivariate logistic regression models were fitted to explore independent factors for selection bias. Results A total of 22,364 colonoscopies were reported to the National Patient Register of which 15,855 (71 %) were registered in Gastronet. Feedback was received from 11,079 patients (50 %). The frequency of AEs increased from 0.6 % in completeness group < 50 % to 1.6 % in completeness group ≥ 90 % ( P  < 0.001). Long colonoscopy procedure time was associated with low reporting completeness. Patient feedback was associated with older age, cecal intubation success and sedation-free colonoscopy. Conclusion Incomplete registration in a colonoscopy quality register is associated with underreporting of AEs. Longer procedure time, a surrogate marker for time constraint, is associated with low completeness.