Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study.

BACKGROUND: In sharp bends, particularly in the colonic flexures, the axial pushing force conveyed to the distal actively bending tip of the endoscope may cause impaction rather than progression. It is hypothesized that colonoscopes with a very flaccid segment immediately proximal to the distal bending tip might reduce this problem. MATERIAL AND METHODS: Two prototype colonoscopes with a flaccid passively bending segment (either progressively graded or ungraded flaccidity) positioned immediately proximal to the distal actively bending tip was evaluated in a single-blinded randomized study. The primary end-point was patients' evaluation of pain. RESULTS: Altogether, 400 patients were randomized 1:1 to examination with a prototype (60 patients to endoscope with graded flaccidity; 141 to the endoscope with ungraded flaccidity) or a standard colonoscope. The groups were similar regarding age, sex and previous abdominal surgery. Severe pain was reported by 7% of patients in the prototype and 18% in the standard group (p = 0.001). There was a trend toward shorter cecal intubation time in the prototype group (mean 14.1 min, 95% CI 12.8-15.3) compared to the standard group (mean 15.5 min, 95% CI 14.3-16.7) (p = 0.12) and similar intubation rates (89% and 85%, respectively). Results for first (ungraded flaccidity) and second (graded flaccidity) generation prototypes collectively were similar to the second generation separately. CONCLUSIONS: The concept of an endoscope with a hyper-flaccid segment may facilitate negotiation of sharp bends and reduce pain without compromising cecal intubation rate or intubation time.

Clustering in time of familial IBD separates ulcerative colitis from Crohn's disease.

BACKGROUND: The aim was to compare clustering of time at diagnosis and phenotype of inflammatory bowel disease (IBD) between affected parents and children and to explore generational differences in age at diagnosis (AAD) as well as the concordance of clinical characteristics. METHODS: Eighty-four affected pairs from 45 families were included from 5 counties in southeastern Norway between August 2003 and December 2006; 43 were sib-sib pairs and 39 parent-child pairs. Clinical data were obtained by phone interviews and by hospital records. RESULTS: The difference in median AAD was 17.0 years (P < 0.001) and 2.0 years (P = 0.29) in parent-child and sib-sib pairs, respectively. When the time interval between diagnosis in parent and child was split into 2 groups, below and above 5 years, 64% of pairs with ulcerative colitis (UC) offspring were diagnosed within 5 years, compared to 24% of pairs with Crohn's disease (CD) offspring (odds ratio [OR] = 5.7, 95% confidence interval [CI]: 1.4, 23.8). Concordance for smoking habits was low in 26 pairs with mixed disease (κ = 0.15), whereas patients with CD tended to be current smokers. CONCLUSIONS: Most of the children acquire their disease at an earlier time in life compared to their parents, suggesting genetic anticipation. The time interval between diagnosis of the parents and offspring was lower when the offspring developed UC compared to CD, which might reflect the influence of shared environment on the generational difference in AAD in UC families. This study confirmed the effect of smoking habits on IBD phenotype.

Predictive value of serologic markers in a population-based Norwegian cohort with inflammatory bowel disease.

BACKGROUND: Perinuclear antineutrophil cytoplasmic antibodies (pANCA) and anti-Saccharomyces cerevisiae antibodies (ASCA) are proposed to be specific markers for ulcerative colitis (UC) and Crohn's disease (CD). Their prevalence and relationship to disease phenotype and outcome in unselected cohorts of patients with inflammatory bowel disease (IBD), however, is largely unclear. We studied the prevalence of these serologic markers in a population-based IBD cohort 10 years after diagnosis, and examined whether their presence could be related to distinct subgroups and outcome of disease. METHODS: Of 685 living IBD patients, 620 met for a 10-year follow-up, of whom 526 (UC, n = 357 and CD, n = 169) participated in this study. RESULTS: Twenty-seven percent (n = 46) of CD patients were ASCA-positive and 31% (n = 109) of UC patients were pANCA-positive. Positive ASCA was more frequent in CD patients with stricturing (P = 0.003) or penetrating (P = 0.012) complications than in those with inflammatory behavior at diagnosis. Moreover, the presence of ASCA was associated with an at least twice higher risk of evolving more severe disease behavior during follow-up (P < 0.001). In UC, pANCA expression was related to female gender (P = 0.005) and the use of azathioprine (P < 0.001), and in CD, to colon-limited disease and age >/=40 years at diagnosis (P = 0.009 and P = 0.001, respectively). CONCLUSIONS: The prevalence of ASCA in CD and pANCA in UC appears markedly lower than in referral-based populations. Even with the low prevalence, our study gives further support to the role of ASCA and pANCA as markers for distinct phenotype and outcome of disease.

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.

Familial aggregation in Crohn's disease and ulcerative colitis in a Norwegian population-based cohort followed for ten years.

BACKGROUND AND AIMS: To explore the change in risk among 1st degree relatives of ulcerative colitis (UC) and Crohn's disease (CD) for development of concordant disease in an incidence cohort followed for ten years. Furthermore, we wanted to compare familial and sporadic cases regarding clinical characteristics and the course of the disease. METHODS: This population-based study included 421 patients with UC and 197 with CD enrolled from 1990 to 1994. Clinical characteristics and the number of 1st degree relatives of the patients were recorded continuously during ten years. RESULTS: Age at diagnosis in CD patients (OR=0.95, 95% CI: 0.93-0.98) and cumulative relapse rate in UC patients (OR=4.91, 95% CI=1.16, 20.75) were significantly associated to familial clustering. Based on the calculated population prevalence of CD (262/100000) and UC (505/100000), the age-adjusted risk for development of concordant disease was 25.9 and 8.6 among siblings and parents of CD, respectively. In UC, the corresponding risks were 8.6 and 1.5. In the course of ten years the increase in risk was observed only among siblings (28%) and parents (97%) of UC, in contrast to no increase in CD. Moreover, the concordance for UC was high in three generations. CONCLUSIONS: Our study confirmed the importance of genetic influence on the development of CD. Within an observation period of ten years, the increased concordance and relapse rate in familial UC, might point to a larger genetic component in UC than previously suggested.

Patients' satisfaction: an important factor in quality control of gastroscopies.

OBJECTIVE: Although oesophagogastroduodenoscopies (OGDs) are associated with few medical complications, substantial pre-procedural anxiety and discomfort during the procedure have been reported. The aims of the present study were to evaluate OGD-related discomfort assessed by the patient and to identify the possibilities for improvement. MATERIAL AND METHODS: All outpatients undergoing OGDs at a single centre during 2004 were eligible for the study. On site, the endoscopy team completed a questionnaire on age of patients, gender and the use of sedation/anaesthesia. After the examination, the patients were given a questionnaire focusing on discomfort during and after the examination. The questionnaire was to be completed at home the following day and returned in a prepaid envelope. RESULTS: During the study period, 1283 examinations were registered, giving 92% coverage of OGDs. The patient response rate was 80%. Patients' mean age was 55 years, and 45% were men. The sedation rate was 7.3%. None or only slight discomfort was experienced by 68% of the patients and severe discomfort by 14%. In patients, the odds ratio (OR) for experiencing moderate or severe discomfort decreased with increasing age (OR 0.96, 95% CI 0.95-0.97, p < 0.001). There were significant differences in patient discomfort depending on the level of experience of the endoscopists. CONCLUSIONS: The majority of patients reported no or only slight discomfort during the examination, but as many as 32% did not. Increased use of sedation in selected patients is recommended. Our quality assurance program included a limited number of variables for registration, with satisfactory compliance by endoscopists and patients.

Clinical course in Crohn's disease: results of a Norwegian population-based ten-year follow-up study.

BACKGROUND & AIMS: Most studies concerning the clinical course in CD are retrospective or based on selected patient groups. Our aim was to assess the course of CD in a prospective population-based follow-up study and to identify possible prognostic risk factors for complications on the basis of information obtained at initial diagnosis. METHODS: From 1990-1994, a population-based cohort of 843 new cases of inflammatory bowel disease was recruited in South-Eastern Norway. The cohort was systematically followed up at 1, 5, and 10 years after diagnosis. RESULTS: Of 237 patients classified as CD, 197 completed the 10 years of follow-up, 18 died, and 22 were lost to follow-up. The cumulative relapse rate during the first 10 years was 90% (95% confidence interval, 86%-94%), and the cumulative probability of surgery was 37.9% (95% confidence interval, 31.4%-44.4%). Terminal ileal location (P < .001), stricturing (P = .004), penetrating behavior (P < .001), and age younger than 40 years (P = .03) at diagnosis were independent risk factors for subsequent surgery. A total of 53% (n = 105) of the patients had developed stricturing or penetrating disease at 10 years. A large proportion of patients (44%) were in clinical remission during the last 5 years of follow-up. CONCLUSIONS: The prognosis for CD seems better than previously reported. The probability of surgery was low, and fewer than expected developed complicated disease behavior. Nevertheless, the cumulative relapse rate of 90% and the finding of prognostic risk factors for subsequent surgery might call for attention to early effective medical treatment strategies.

Improvement in caecal intubation rate and pain reduction by using 3-dimensional magnetic imaging for unsedated colonoscopy: a randomized trial of patients referred for colonoscopy.

OBJECTIVE: Use of magnetic endoscope imaging (MEI) during colonoscopy has the potential to ease caecal intubation and patient discomfort and to reduce dependence on sedation and/or analgesics (SAs). However, pain reduction by using MEI has not been demonstrated so far, probably because of the liberal use of SAs. The aim of the present study was to evaluate the effect of MEI on caecal intubation and patient pain during unsedated colonoscopy performed by experienced and inexperienced colonoscopists. MATERIAL AND METHODS: A consecutive series of outpatients referred for colonoscopy were randomly allocated to examination with (imager group) or without (standard group) the use of MEI. Patients agreeing to SAs being given only on demand were included in the study. End-points were caecal intubation and pain, the latter to be graded by category on a form to be completed on the day after the examination. RESULTS: The proportion of colonoscopies performed without SAs was similar when comparing imager and standard groups and experienced with inexperienced colonoscopists; altogether 367(88%) out of 419 colonoscopies. The caecal intubation rate was higher in the imager group (190/212 (90%)) than in the standard group (153/207(74%)) (p<0.001), both collectively and separately for experienced and inexperienced colonoscopists. A pain-reducing effect of MEI was shown only when performed by experienced colonoscopists, with severe pain in 10/137 patients (7.3%) in the imager group and 21/132 patients (16%) in the standard group (p=0.03). CONCLUSIONS: In colonoscopy without the routine use of SAs, MEI significantly improves the caecum intubation rate and reduces pain during the procedure.

Change of diagnosis during the first five years after onset of inflammatory bowel disease: results of a prospective follow-up study (the IBSEN Study).

OBJECTIVE: An exact diagnosis of inflammatory bowel disease (IBD) and further subclassification may be difficult even after clinical, radiological and histological examinations. A correct subclassification is important for the success of both medical and surgical therapeutic strategies, but there is a dearth of information available on the frequency of changes in diagnosis in population-based studies. The objective of this work was prospectively to re-evaluate the diagnosis in an unselected cohort of IBD patients during the first five years after the initial diagnosis. MATERIAL AND METHODS: Patients classified as IBD or possible IBD in the period 1990-94 (the IBSEN cohort) had their diagnosis re-evaluated after 1 and 5 years. Initially, the patients were classified as ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis (IC) or possible IBD. At the 5-year visit, patients were classified as UC, CD or non-IBD. RESULTS: A total of 843 patients (518 UC, 221 CD, 40 IC and 64 possible IBD) were identified. Clinical information was available for 94% of the patients who survived after 5 years. A change in diagnosis was found in 9% of the patients initially classified as UC or CD. A change to non-IBD was more frequent than a change between UC and CD. A large proportion of patients initially classified as IC or possible IBD were diagnosed as non-IBD after 5 years (22.5% versus 50%). When IBD was confirmed in these groups, UC was more frequent than CD. Two changes in diagnosis during follow-up were observed in 2.8% of the patients; this was more frequent in patients initially classified as IC or possible IBD. CONCLUSIONS: There are obvious diagnostic problems in a minority of patients with IBD; a systematic follow-up is therefore important in these patients.

Ulcerative colitis and clinical course: results of a 5-year population-based follow-up study (the IBSEN study).

BACKGROUND: The majority of studies concerning the clinical course and prognosis in ulcerative colitis (UC) are old, retrospective in design, or hospital based. We aimed to identify clinical course and prognosis in a prospective, population-based follow-up study MATERIALS AND METHODS: Patients diagnosed with inflammatory bowel disease (IBD) or possible IBD in southeastern Norway during the period 1990-1994 were followed prospectively for 5 years. The evaluation at 5 years included an interview, clinical examination, laboratory tests, and colonoscopy. RESULTS: Of 843 patients diagnosed with IBD, 454 patients who had definite UC and for whom there were sufficient data for analysis were alive 5 years after inclusion in the study. The frequency of colectomy in this population was 7.5%. Forty-one percent of the patients were not taking any kind of medication for IBD at 5 years. Of the patients initially diagnosed with proctitis, 28% had progressed during the observation period, 10% to extensive colitis. The majority of the patients (57%) had no intestinal symptoms at 5 years, and only a minority (7%) had symptoms that interfered with everyday activities. Among the patients who underwent colonoscopy at the 5-year visit, symptoms were frequently reported in patients without macroscopic inflammation (44%). A relapse-free course was observed in 22% of the patients. A decrease in symptoms during the follow-up period was the most frequent course taken by the disease and was observed in 59% of the cases. The extent of disease was unrelated to symptoms at 5 years and also to relapse rate and course of disease during the 5-year period. CONCLUSIONS: The disease course and prognosis of UC appears better than previously described in the literature. The frequency of surgery was low, and only a minority of the patients had symptoms that interfered with their everyday activities 5 years after diagnosis.

Relationship between sick leave, unemployment, disability, and health-related quality of life in patients with inflammatory bowel disease.

BACKGROUND: The goal of this study was to determine the rate of work disability, unemployment, and sick leave in an unselected inflammatory bowel disease (IBD) cohort and to measure the effect of working status and disability on the patient's health-related quality of life (HRQOL). MATERIALS AND METHODS: All eligible patients were clinically examined and interviewed at the 5-year follow-up visit. In addition, they completed the 2 HRQOL questionnaires, the Short Form-36 Health Survey (SF-36) and the Inflammatory Bowel Disease Questionnaire validated for use in Norway (N-IBDQ). Data regarding sick leave, unemployment, and disability pension (DP) also were collected. RESULTS: All together, 495 patients were or had been in the workforce during the 5-year follow-up period since diagnosis. Forty-two patients (8.5%) were on DP compared with 8.8% in the background population. Women with Crohn's disease (CD) had the highest probability of receiving DP (24.6%). A total of 58 patients (11.7%) reported they were unemployed at 5 years. This was equally distributed between men and women but was more frequent in patients with ulcerative colitis. Sick leave for all causes was reported in 47% with ulcerative colitis and 53% with CD, whereas IBD-related sick leave was reported in 18% and 23%, respectively. A majority (75%) had been sick <4 weeks, and a relatively small number of patients (25%) contributed to a large number of the total sick leave days. Both unemployment and DP reduced HRQOL scores, but the most pronounced effect on HRQOL was found in patients reporting IBD-related sick leave, measured with SF-36 and N-IBDQ. The observed differences also were highly clinically significant. Multiple regression analysis confirmed that IBD-related sick leave was the independent variable with the strongest association to the observed reduction in HRQOL scores. CONCLUSIONS: Unemployment or sick leave is more common in IBD patients than in the Norwegian background population. The number of patients receiving DP is significantly increased in women with CD but not in the other patient groups. Unemployment, sick leave, and DP are related to the patient's HRQOL in a negative way, but this effect is most pronounced in patients reporting IBD-related sick leave.

Course of disease, drug treatment and health-related quality of life in patients with inflammatory bowel disease 5 years after initial diagnosis.

OBJECTIVES: We assessed health-related quality of life (HRQOL) on the basis of a cross-sectional design in a population-based cohort of inflammatory bowel disease patients followed prospectively for 5 years after diagnosis. The aim was to investigate the influence of the course of disease, drug therapy, and relapse pattern on the patients' HRQOL. METHODS: All patients completed the validated Norwegian version of the Inflammatory Bowel Disease Questionnaire (N-IBDQ). We present data from 497 patients, 328 with ulcerative colitis and 169 with Crohn's disease. The mean age was 43.3 years, and 48% were female. RESULTS: Crohn's disease patients treated with systemic steroids or azathioprine had a statistically significant reduction in the N-IBDQ total score compared with non-users. Patients with a more severe disease pattern had a lower N-IBDQ total score. Patients reporting a relapse during the observation period had a significantly lower total score and dimension scores than patients without relapse in both diagnostic groups, and likewise there was a statistically significant decrease in N-IBDQ total score for those with extra-intestinal manifestations compared with those without. A multiple linear regression model showed that the number of relapses during the preceding year in ulcerative colitis, and sex (female gender) in Crohn's disease were the strongest predictor of a reduction in N-IBDQ total score. CONCLUSION: Treatment with systemic steroids or immunosuppressive drugs, a relapsing disease and the presence of extra-intestinal manifestations were associated with a clinically significant reduction in the patients' HRQOL.

[Systematic quality control programme for colonoscopy in an endoscopy centre in Norway]. / Systematisk kvalitetskontroll av koloskopier.

BACKGROUND: Colonoscopy is regarded as the gold standard for diagnosis of colorectal disease, and increasingly considered a primary screening approach for colorectal cancer. The quality of the procedure varies between centres and endoscopists. The aim of the present study was to describe a quality control programme for colonoscopy performance in a secondary care centre. MATERIAL AND METHODS: Starting in 2001, we established a systematic quality control programme. All patients received a questionnaire on their satisfaction with and pain during and after examination. The questionnaire was to be filled in the next day and mailed back to the centre. Pain and discomfort during and after colonoscopy and caecum intubation rate were registered as indicators of quality. RESULTS: During the study period of 15 month, 1354 colonoscopies were performed by 16 endoscopists. 94% of examinations were performed without any sedation. 1054 (78%) of patients responded to the questionnaire, 99% of whom were generally satisfied. The caecum intubation rate was 82%. While 23% of patients scored for moderate pain during the examination and 16% complained of severe pain, 61% had no or only light pain. Significant differences between endoscopists regarding pain and caecum intubation rate were found in a multiple logistic regression model. INTERPRETATION: A satisfactory feedback from patients was observed, with a high response rate to the questionnaire survey and high overall satisfaction, in spite of the fact that about one third of patients experienced moderate or severe pain. There were significant variations in performance between endoscopists.