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.

Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial.

BACKGROUND AND STUDY AIMS: Colonoscopy is frequently performed with opioid analgesia, but the impact of drug delivery timing has not been studied in detail. Low-dose opioids administered before the procedure may provide better pain control than on-demand administration when the patient experiences pain. PATIENTS AND METHODS: A total of 119 outpatients were randomized to receive 50 µg of fentanyl either before colonoscopy (routine group) or on demand if needed during the colonoscopy (on-demand group). Additional fentanyl or midazolam was allowed in both groups if required. The primary outcome was pain measured on both a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst possible pain) and a four-point Likert scale (no, slight, moderate, or severe pain) immediately after the procedure. RESULTS: A total of 61 patients in the routine group and 58 patients in the on-demand group were included in the study. Mean VAS pain scores were 27.4 mm in the routine group and 30.5 mm in the on-demand group (mean difference - 3.2 mm; 95 % confidence interval - 11.9 to 5.5; P = 0.5). On the Likert scale, moderate or severe pain was experienced by 25.0 % and 31.5 % of patients in the routine and on-demand groups, respectively (p = 0.5). Cecal intubation rate and time to reach the cecum were similar between the groups. More patients in the on-demand group (81.0 %) than in the routine group (62.3 %) were able to leave the clinic without the need for recovery time (P = 0.03). CONCLUSION: Routine administration of fentanyl did not provide better analgesia during colonoscopy than on-demand fentanyl, and more patients needed time for recovery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01786434).

Water exchange versus carbon dioxide insufflation in unsedated colonoscopy: a multicenter randomized controlled trial.

BACKGROUND AND STUDY AIMS: Compared with air insufflation, water exchange and carbon dioxide (CO2) insufflation have been shown to reduce colonoscopy discomfort; however, head-to-head studies of the two methods are lacking. We aimed to compare water exchange and CO2 insufflation directly with regard to pain during primary unsedated colonoscopy. METHODS: Patients willing to undergo unsedated colonoscopy at three centers in Norway and Poland were randomized 1:1 to water exchange or CO2 insufflation during colonoscope insertion. Patients were blinded to group allocation. The primary end point was the proportion of patients reporting moderate or severe procedural pain on a 4-point verbal rating scale (VRS-4) at discharge. Secondary outcomes included the proportion of patients reporting no pain on the VRS-4. RESULTS: A total of 473 patients were randomized. A discharge pain questionnaire was completed by 226 of 234 patients (97 %) in the water exchange group versus 226 of 239 patients (95 %) in the CO2 group (P = 0.37). Moderate or severe pain was reported by 47 of 226 patients (21 %) in the water exchange group versus 60 of 226 patients (27 %) in the CO2 group (P = 0.15). No pain was reported by 100 of 226 patients (44 %) and 69 of 226 patients (31 %) in the water exchange and CO2 groups, respectively (P = 0.003). On-demand sedation was used in 15 patients (6 %) in each group (P = 0.95). CONCLUSIONS: There was no significant reduction in moderate or severe pain in a comparison of water exchange with CO2 insufflation. The secondary outcome of no pain was significantly more frequent in the water exchange group. Clinical trials registry number: NCT01633333.

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.).

Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial.

BACKGROUND: Colonoscopes with gradual stiffness have recently been developed to enhance cecal intubation. OBJECTIVE: We aimed to determine if the performance of gradual stiffness colonoscopes is noninferior to that of magnetic endoscopic imaging (MEI)-guided variable stiffness colonoscopes. METHODS: Consecutive patients were randomized to screening colonoscopy with Fujifilm gradual stiffness or Olympus MEI-guided variable stiffness colonoscopes. The primary endpoint was cecal intubation rate (noninferiority limit 5%). Secondary endpoints included cecal intubation time. We estimated absolute risk differences with 95% confidence intervals (CIs). RESULTS: We enrolled 475 patients: 222 randomized to the gradual stiffness instrument, and 253 to the MEI-guided variable stiffness instrument. Cecal intubation rate was 91.7% in the gradual stiffness group versus 95.6% in the variable stiffness group. The adjusted absolute risk for cecal intubation failure was 4.3% higher in the gradual stiffness group than in the variable stiffness group (upper CI border 8.1%). Median cecal intubation time was 13 minutes in the gradual stiffness group and 10 minutes in the variable stiffness group (p < 0.001). CONCLUSIONS: The study is inconclusive with regard to noninferiority because the 95% CI for the difference in cecal intubation rate between the groups crosses the noninferiority margin. (ClinicalTrials.gov identifier: NCT01895504).