Continuous monitoring of colonoscopy performance in the Netherlands: first results of a nationwide registry.

BACKGROUND: To optimize colonoscopy quality, several performance measures have been developed. These are usually assessed without distinction between the indications for colonoscopy. This study aimed to assess the feasibility of linking two national registries (one for colonoscopy and one for adverse events of gastrointestinal endoscopies in the Netherlands), and to describe the results of colonoscopy quality per indication. METHODS: This retrospective study was conducted with prospectively collected data of the Dutch Gastrointestinal Endoscopy Audit (DGEA) and the Dutch Registration of Complications in Endoscopy (DRCE). Data between 01-01-2016 and 01-01-2019 were analyzed. To calculate adverse event rates, data were linked at the level of endoscopy service. RESULTS: During the 3-year study period, 266 981 colonoscopies were recorded in DGEA. Of all indications, cecal intubation rate was highest in fecal immunochemical test (FIT)-positive screening colonoscopies (97.1 %), followed by surveillance (93.2 %), diagnostic (90.7 %), and therapeutic colonoscopies (83.1 %). The highest rate of adequate bowel preparation was observed in FIT-positive screening colonoscopies (97.1 %). A total of 1540 colonoscopy-related adverse events occurred (0.58 % of all colonoscopies). Bleeding and perforation and rates were highest for therapeutic (1.56 % and 0.51 %, respectively) and FIT-positive screening (0.72 % and 0.06 %, respectively) colonoscopies. The colonoscopy-related mortality was 0.006 %. CONCLUSION: This study describes the first results of the Dutch national colonoscopy registry, which was successfully linked to data from the national registry for adverse events of gastrointestinal endoscopies. In this large dataset, performance varied between indications. Our results emphasize the importance of defining benchmarks per indication in future guidelines.

Computer-based patient education is non-inferior to nurse counselling prior to colonoscopy: a multicenter randomized controlled trial.

BACKGROUND: Optimal patient education prior to colonoscopy improves adherence to instructions for bowel preparation and leads to cleaner colons. We developed computer-based education (CBE) supported by video and 3 D animations. We hypothesized that CBE could replace nurse counselling without loss of bowel preparation quality during colonoscopy. METHODS: We conducted a prospective, multicenter, endoscopist-blinded, non-inferiority randomized controlled trial. The primary outcome was adequate bowel preparation, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcome measures were: sickness absence for outpatient clinic visits; patient anxiety/satisfaction scores; and information recall. We included patients in four endoscopy units (rural, urban, and tertiary). RESULTS: We screened 1035 eligible patients and randomized 845. After evaluation, 684 were included in the intention-to-treat (ITT) group. Subsequently, 497 patients were included in the per-protocol analysis, 217 in the nurse counselling and 280 in the CBE group. Baseline characteristics were similarly distributed among the groups. On per-protocol analysis, adequate bowel cleansing was achieved in 93.2 % (261/280) of CBE patients, which was non-inferior to nurse-counselled patients (94.0 %; 204/217), with a difference of -0.8 % (95 % confidence interval [CI] -5.1 % to 3.5 %). Non-inferiority was confirmed in the ITT population. Sickness absence was significantly more frequent in nurse-counselled patients (28.0 % vs. 4.8 %). In CBE patients, 21.5 % needed additional information, with 3.0 % needing an extra outpatient visit. CONCLUSION: CBE is non-inferior to nurse counselling in terms of bowel preparation during colonoscopy, with lower patient sickness leave. CBE may serve as an efficient educational tool to inform patients before colonoscopy in routine clinical practice.

Dutch Gastrointestinal Endoscopy Audit: automated extraction of colonoscopy data for quality assessment and improvement.

BACKGROUND AND AIMS: The importance of having quality assessment, assurance, and improvement tools in health care is increasingly recognized. However, the additional associated administration burden progressively interferes with the structural implementation and adoption of such tools, especially when it concerns high-volume procedures such as colonoscopies. The development of the Dutch Gastrointestinal Endoscopy Audit (DGEA), a registry with automated extraction of colonoscopy quality data, and its first results are described. METHODS: In close cooperation with commercial endoscopy reporting systems and a national histopathology database, healthcare professionals performing colonoscopies initiated a quality registry that extracts data from its core hospital resource or histology database without manual interference of the healthcare providers. Data extracted consisted of patient age, gender, indication of the colonoscopy, American Society of Anesthesiologists score, Boston Bowel Preparation Score, and cecal intubation; for the colonoscopy after a positive fecal immunochemical test in the colorectal cancer screening program, other data were polyp detection rate, which was available for all 48 hospitals or endoscopy centers, and adenoma detection rate, which was available for 26 hospitals or endoscopy centers. RESULTS: Between January 1, 2016 and March 31, 2019, 48 hospitals or endoscopy centers voluntarily participated in the DGEA, and 275,017 unique patients with 313,511 colonoscopies were registered. Overall missing values were limited to <1%. CONCLUSIONS: The results of this study demonstrate that it is feasible to deploy a quality registry collecting uniform data without additional administration burden for healthcare professionals.

A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study.

BACKGROUND: The importance of high quality preprocedural bowel preparation is widely acknowledged, but suboptimal bowel cleansing still occurs in up to 20 % of all colonoscopy patients. The aim of this study was to evaluate the performance of a novel intraprocedural cleaning device for cleaning poorly prepared colons. METHODS: This multicenter feasibility study included patients aged 18 - 75 years who were referred for colonoscopy. Intraprocedural cleaning was performed in patients after a limited preprocedural bowel preparation regimen (2 days of dietary restrictions and 2 × 10 mg bisacodyl). The primary outcome was the proportion of adequately prepared patients (Boston Bowel Preparation scale [BBPS] ≥ 2 in each segment) before and after segmental washing with the new device. Secondary outcomes included: cecal intubation rate, procedure time, system usability, patient satisfaction, and safety. RESULTS: 47 patients (42.6 % male), with a median age of 61 years (interquartile range [IQR] 46 - 67 years), were included at three clinical sites. Cecal intubation was achieved in 46/47 patients (97.9 %). The cleaning device significantly improved the proportion of patients with adequate bowel cleansing (from 19.1 % to 97.9 %; P < 0.001) and median BBPS score (from 3.0 [IQR 0.0 - 5.0] to 9.0 [IQR 8.0 - 9.0]). Median cecal intubation time and total procedure time were 16.5 minutes (IQR 9.0-28.3) and 34.0 minutes (IQR 25.0 - 42.8), respectively. Physicians were satisfied with the ease of use of the device and it was well tolerated by patients. No severe adverse events occurred during the study period. CONCLUSIONS: This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.

Long-Term Clinical Outcomes After Switching from Remicade® to Biosimilar CT-P13 in Inflammatory Bowel Disease.

BACKGROUND: Limited data are available on long-term clinical outcomes regarding the switch from Remicade® to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients. AIMS: To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity. METHODS: We performed a single-center prospective observational cohort study following an elective switch from Remicade® to CT-P13 in IBD patients. RESULTS: Eighty-three patients were included (57 Crohn's disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up. Disease activity (Harvey-Bradshaw Index and Simple Clinical Colitis Activity Index) as well as inflammatory markers (CRP, fecal calprotectin) did not change significantly during the 1-year follow-up. In total, 7 out of 83 patients (8%) demonstrated detectable antidrug antibodies during follow-up, and 5 out of 7 antidrug antibody titers were already detectable at baseline prior to switching. Six patients (7%) discontinued CT-P13 due to adverse events. CONCLUSIONS: Following a switch from Remicade® to CT-P13, 82% of IBD patients continued treatment through 1 year. Disease activity scores and inflammatory markers remained unchanged during follow-up, and no CT-P13-related serious adverse events occurred. These 1-year data suggest that switching to CT-P13 in Remicade®-treated IBD patients is safe and feasible.

A wide variation in diagnostic and therapeutic strategies in chronic pancreatitis: a Dutch national survey.

CONTEXT: Optimal diagnostic and treatment modalities in chronic pancreatitis are controversial due to lack of evidence. OBJECTIVE: To evaluate current clinical practice, we conducted a survey with the primary objective to evaluate decisions regarding the diagnosis, management and screening in chronic pancreatitis. DESIGN: We developed a vignette survey. SETTING: We surveyed Dutch gastroenterologists, internists, gastrointestinal surgeons and an international expert panel. RESULTS: A total of 110 questionnaires (31% gastroenterologists, 39% internists and 20% gastrointestinal surgeons) were returned out of the 1,324 sent (response 8.3%). There was a wide variation in strategies regarding diagnosis, treatment and screening in chronic pancreatitis. As a diagnostic test, serum amylase is used frequently by internists, while gastroenterologists and experts often use fecal elastase. Most respondents preferred CT-scanning for diagnosis, while experts preferred transabdominal ultrasonography as an initial test. Respondents frequently use pancreatic enzymes for treatment of pain in chronic pancreatitis. The majority advised to perform an intervention (endoscopic or surgical) in case of morphological changes of the pancreatic duct. CONCLUSIONS: The results of our survey identify important differences between physicians in diagnosis and management of chronic pancreatitis. This is often due to lack of evidence and consensus in literature. Certain wide-spread practices are in contrast with available evidence, and should be addressed by improved education and adherence to guidelines.

Virtual reality distraction for patients to relieve pain and discomfort during colonoscopy.

Background and study aims Colonoscopy is an invasive procedure that may cause patients pain and discomfort. Routine use of sedation, while effective, is expensive and requires logistical planning. Virtual reality (VR) offers immersive, three-dimensional experiences that distract the attention and might comfort patients. We performed a pilot study to investigate the feasibility of VR distraction during colonoscopy. Patients and methods Adults referred for colonoscopy were considered for inclusion and divided over two groups: with and without VR glasses. The main outcome was patient acceptance of wearing VR glasses during colonoscopy without compromising the technical success of the procedure. Secondary outcomes were patient comfort, pain, and anxiety before, during and after the procedure, using validated patient questionnaires. Patient comments were collected through a qualitative interview. Results We included 19 patients, 10 of whom were offered VR glasses. All patients accepted VR glasses without prolonging procedural time. No disadvantages of the VR glasses were reported in terms of communication or change of position of the patient. We found that patient comfort, pain, anxiety, and satisfaction in relation to the procedure were similar in both groups. Patients described a pleasant distracting effect using VR glasses. Conclusion VR glasses during colonoscopy are accepted by patients and do not compromise endoscopic technical success. Patients reported that the VR experience was pleasant and distracting.

The gastrointestinal endoscopy satisfaction questionnaire captures patient satisfaction as a key quality indicator of gastrointestinal endoscopy.

BACKGROUND: Patient satisfaction is a crucial indicator of gastrointestinal endoscopy quality. The gastrointestinal endoscopy satisfaction questionnaire (GESQ) was validated for the assessment of patient satisfaction undergoing endoscopy in English with good validity. We translated and validated the GESQ in Dutch. METHODS: The original GESQ was translated in Dutch according to the WHO guidelines. First, an internal validation of the Dutch GESQ (D-GESQ) was established by the think-aloud method and subsequent expert panel analysis. Next, the D-GESQ was embedded in the computer-based education (CBE) program in our unit, with 30-day interval after endoscopy. Adult patients, informed via CBE after undergone endoscopy, were included. Exclusion criteria were conscious sedation, limited language skills, no e-mail address available, dementia and visual impairment. For statistical analysis, several psychometric analyses were performed to identify the underlying dimensions and assessed the questionnaire for reliability and validity. RESULTS: In total, 227 of 1065 patients completed the D-GESQ, a response rate of 21.3%. Men comprised 52.6% (n = 129) of patients. Mean age was 62.7 ± 11.54 years. In total, 180 patients (79.3%) had previously undergone endoscopy, with 157 (87.2%) of them two or more times. The exploratory factor analysis showed the 21 questions could best be clustered into five clusters instead of four in the original GESQ. The D-GESQ had an overall Cronbach α of 0.88, confirming the high internal validity. CONCLUSION: The Dutch version of the GESQ showed high internal validity and practicality. We recommend the D-GESQ for routine use in endoscopy practice to improve quality of patient care.

Polymorphisms in gene encoding TRPV1-receptor involved in pain perception are unrelated to chronic pancreatitis.

BACKGROUND: The major clinical feature in chronic pancreatitis is pain, but the genetic basis of pancreatic pain in chronic pancreatitis is poorly understood. The transient receptor potential vanilloid receptor 1 (TRPV1) gene has been associated with pain perception, and genetic variations in TRPV1 may modify the presence and phenotype of chronic pancreatitis. The aim of our study was to investigate the genetic variation of TRPV1 in Dutch patients with chronic pancreatitis and healthy controls. METHODS: We genotyped 4 SNPs (rs222749, rs222747, rs224534 and rs8065080) in 228 chronic pancreatitis-patients and 207 healthy controls by PCR, followed by restriction-fragment-length-polymorphism analysis and DNA sequencing. We generated 27 diplotypes and compared prevalence between patients and controls. RESULTS: There was no significant difference in allele frequency of the 4 TRPV1 gene SNPs in patients with chronic pancreatitis and healthy controls. Distribution of diplotypes was not statistically significantly different between patients and controls. CONCLUSION: TRPV1 diplotypes are not associated with chronic pancreatitis.

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy.

Improving patient education focusing on bowel preparation before a colonoscopy leads to cleaner colons. Endoscopy units must obtain informed consent and perform a risk assessment for sedative use prior to a colonoscopy. The current practice in the Netherlands to achieve these goals is nurse counseling in an outpatient setting. This is costly and has disadvantages in terms of uniformity and time consumption for both the patient and the hospital. The hypothesis is that computer-based education with use of video and 3D animations may replace nurse counseling in most cases, without losing quality of bowel cleanliness during colonoscopy. This multicenter, randomized, endoscopist blinded clinical trial evaluates a primary outcome measure (bowel preparation) during colonoscopy. Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call. The study will be performed in four endoscopy units of different levels (rural, urban, and tertiary). Inclusion criteria are adult age and referral for complete colonoscopy. Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access. This trial aims to establish online computer-based education as tool for patient education prior to a colonoscopy. By choosing a direct comparison with the standard of care (nurse counseling), both endoscopic quality measures and patient related outcome measures can be evaluated.

Drug Survival and Immunogenicity After Switching From Remicade to Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: Two-year Follow-up of a Prospective Observational Cohort Study.

Background: The infliximab biosimilar has entered daily inflammatory bowel disease (IBD) practice. However, real-life outcomes beyond 1 year after switching are scarce. We aimed to investigate the long-term drug survival, immunogenicity, and pharmacokinetics 2 years after switching to CT-P13 in IBD patients. Methods: We performed a single-center prospective observational cohort study in all Remicade-treated IBD patients who previously switched to CT-P13. We systematically documented reasons for discontinuation, trough levels, and antidrug antibodies to infliximab (ADAs) at baseline, week 16, week 52, and week 104. Clinical and biochemical disease activity (HBI, SCCAI, CRP) and adverse events were registered. Results: Eighty-three patients were enrolled, 57 had Crohn's disease, 24 had ulcerative colitis, and 2 were IBD-unclassified. At week 104, 55 of 83 (66%) patients remained on CT-P13, and 3 were lost to follow-up. Reasons for discontinuation were loss of response (n = 10), adverse events (n = 8), and disease remission (n = 7). ADAs were present in 5/83 patients at baseline (before switching), in 2 patients before week 52, and no subsequent ADAs were detected until week 104. Median trough levels and clinical and biochemical disease activity at baseline, week 16, week 52 and week 104 did not significantly change. Conclusion: In a prospective cohort with >2-year follow-up, 66% of IBD patients continued CT-P13 after switching from Remicade. Two new cases with ADAs were observed in year 1, but subsequently no immunogenicity was detected. These results are reassuring and suggest that switching to CT-P13 does not impact long-term clinical outcomes. 10.1093/ibd/izy227_video1izy227.video15802479819001.

Recurrent idiopathic pancreatitis in familial adenomatous polyposis: report of a case-series and review of the literature.

Familial adenomatous polyposis (FAP) is characterized by the development of multiple adenomatous polyps predominantly in the colon but also in the duodenum. Scattered case reports indicate that there is a risk for pancreatitis in FAP. The most likely cause of pancreatitis in FAP is obstructing ampullary adenomas. We describe 7 FAP patients who experienced one or more episodes of pancreatitis. Two patients experienced pancreatitis after endoscopic treatment of ampullary adenoma. The cause of the pancreatitis in 5 of 7 patients could not be determined, as none of the patients had obstruction of the ampulla. Furthermore, other risk factors for pancreatitis such as pancreatic serine protease inhibitor Kazal type I (SPINK1) gene mutations were ruled out. A review of literature identified 20 FAP patients who developed the first episode of pancreatitis at a mean age of 45 years (range 23-72 years). Some 55% had recurrent episodes of pancreatitis. Eight patients had (peri) ampullary adenomas or carcinomas. In most cases, the course of pancreatitis was mild with an uneventful outcome, but one patient died after an episode of acute pancreatitis.

Specific Radiological Imaging Findings in Patients With Hereditary Pancreatitis During a Long Follow-up of Disease.

OBJECTIVES: Hereditary pancreatitis (HP) is characterized by recurrent episodes of inflammation of the pancreas. Radiological imaging is used to diagnose HP and to monitor complications. The aim of this study was to describe specific imaging findings in HP. METHODS: We retrospectively collected data of HP patients with serial imaging and reviewed all radiological imaging studies (transabdominal ultrasonography, computed tomography, and magnetic resonance imaging). RESULTS: We included 15 HP patients, with a mean age of 32.5 years (range, 9-61 years) and mean disease duration of 24.1 years (range, 6-42 years). In total, 152 imaging studies were reviewed. Seventy-three percent of patients had a dilated main pancreatic duct (MPD) (width 3.5-18 mm). The MPD varied in size during disease course, with temporary reduction in diameter after drainage procedures. A severe dilated MPD (>10 mm) often coincided with presence of intraductal calcifications (size, 1-12 mm). In 73% of patients, pancreatic parenchyma atrophy occurred, which did not correlate with presence of exocrine or endocrine insufficiency. CONCLUSIONS: In HP, the MPD diameter increases with time, mostly without dilated side branches, and is often accompanied by large intraductal calcifications. The size of the MPD is independent of disease state. Atrophy of pancreatic parenchyma is not correlated with exocrine or endocrine insufficiency.

Computer-assisted instruction before colonoscopy is as effective as nurse counselling, a clinical pilot trial.

BACKGROUND AND STUDY AIMS: Better patient education prior to colonoscopy improves adherence to instructions for bowel preparation and leads to cleaner colons. We reasoned that computer assisted instruction (CAI) using video and 3 D animations followed by nurse contact maximizes the effectiveness of nurse counselling, increases proportion of clean colons and improves patient experience. PATIENTS AND METHODS: Adults referred for colonoscopy in a high-volume endoscopy unit in the Netherlands were included. Exclusion criteria were illiteracy in Dutch and audiovisual handicaps. Patients were prospectively divided into 2 groups, 1 group received nurse counselling and 1 group received CAI and a nurse contact before colonoscopy. The main outcome, cleanliness of the colon during examination, was measured with Ottawa Bowel Preparation Scale (OBPS) and Boston Bowel Preparation Scale (BBPS). We assessed patient comfort and anxiety at 3 different time points. RESULTS: We included 385 patients: 197 received traditional nurse counselling and 188 received CAI. Overall patient response rates were 99 %, 76.4 % and 69.9 % respectively. Endoscopists scored cleanliness in 60.8 %. Comparative analysis of the 39.2 % of patients with missing scores showed no significant difference on age, gender or educational level. Baseline characteristics were evenly distributed over the groups. Bowel cleanliness was satisfactory and did not differ amongst groups: nurse vs. CAI group scores in BBPS: (6.54 ±â€Š1.69 vs. 6.42 ±â€Š1.62); OBPS: (6.07 ±â€Š2.53 vs. 5.80 ±â€Š2.90). Patient comfort scores were significantly higher (4.29 ±â€Š0.62 vs. 4.42 ±â€Š0.68) in the CAI group shortly before colonoscopy. Anxiety and knowledge scores were similar. CONCLUSION: CAI is a safe and practical tool to instruct patients before colonoscopy. We recommend the combination of CAI with a short nurse contact for daily practice.

Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study.

BACKGROUND AND AIMS: The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade® to CT-P13 in IBD patients. METHODS: Remicade®-treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospective observational cohort study. Primary endpoint was change in Harvey-Bradshaw Index for Crohn's disease [CD] and Simple Clinical Colitis Activity Index for ulcerative colitis [UC] at week 16. We measured C-reactive protein [CRP], faecal calprotectin [FCP], infliximab trough level [TL] and anti-drug antibodies [ADAs] and documented adverse events. RESULTS: Our cohort consisted of 83 patients (28 males, 57 CD, 24 UC, 2 IBD-unclassified [IBD-U]). The median age was 36 years, range 18-79. Median change in disease activity was 0 [range -23 to +7] for CD and 0 [range -3 to +6] for UC/IBD-U. Median CRP and FCP levels did not change significantly during follow-up. Median TL increased from 3.5 µg/ml [range 0-18] to 4.2 µg/ml [range 0-21] at week 16 [p = 0.010]. Two patients developed a new detectable ADA response during follow-up and five patients discontinued CT-P13. No serious adverse events occurred. CONCLUSIONS: We demonstrated that switching from Remicade® to CT-P13 in a real-life cohort of IBD patients did not have a significant impact on short-term clinical outcomes. These results suggest that switching from Remicade® to CT-P13 for the treatment of IBD is feasible.