The Prediction of Inadequate Colon Capsule Cleansing: A Cohort Selection Guided by CC-CLEAR.

Introduction: In order to optimize the rate of adequate cleansing in colon capsule, it may be important to identify risk factors that can predict a suboptimal colon preparation. Aim: To define predictive factors for inadequate bowel preparation in colon capsule, according to CC-CLEAR (Colon Capsule CLEansing Assessment and Report). Methods: Retrospective, single center, cohort study. Patients' demographics, data, and quality of bowel preparation, according to CC-CLEAR, were collected retrospectively. A univariate analysis tested the association between covariables and the outcome, inadequate cleansing. The statistically significant variables were included in multivariable logistic binary regression, and a receiver operating characteristic curve (ROC) assessment was performed. Results: We included 167 consecutive colon capsules. Sixty-eight percent (n = 114) of patients were female, with a mean age of 64 years. The main indication for colon capsule was previous incomplete colonoscopy, in 158 patients (94.6%). The colon capsules cleansing was graded as good or excellent in 96 patients (57.5%) and as inadequate in 71 (42.5%), according to CC-CLEAR. The variables inadequate previous colon cleansing (OR adjusted 41.72 [95% CI 12.57-138.57], p value < 0.001); chronic laxative (OR adjusted 4.86 [95% CI 1.08-21.79], p value = 0.039); antidepressant (OR adjusted 5.00 [95% CI 1.65-15.16], p value = 0.004), and impaired mobility (OR adjusted 5.54 [95% CI 1.17-26.31], p value = 0.031) were independently associated with the outcome inadequate cleansing, after adjusting for confoundment. The model presented an excellent discriminative power towards the outcome variable (AUC ROC 0.937 [CI 95% 0.899-0.975], p value < 0.001). Conclusion: A previous inadequate colon cleansing, the use of chronic laxative and antidepressant, or impaired mobility are predictors of inadequate colon capsule cleansing, as assessed by the CC-CLEAR. These 4 predictors come together as a model enabling an accurate categorization of the patients at major risk of inadequate bowel preparation for capsule colonoscopy, with an excellent discriminative power and performance, which seems useful for the selection of patients for tailored optimization of the colon cleansing protocol.

Introdução: Com o intuito de otimizar a taxa de preparações intestinais adequadas em cápsula do cólon, poderá ser importante identificar fatores de risco preditivos de preparações sub-ótimas. Objetivo: Definir fatores preditivos de preparação intestinal inadequada em cápsula do colon, de acordo com a CC-CLEAR (Colon Capsule CLEansing Assessment and Report). Métodos: Estudo de coorte retrospetivo, no qual as variáveis demográficas, clínicas e a qualidade de preparação intestinal, de acordo com a CCCLEAR, foram colhidas retrospetivamente. Uma análise univariada testou a associação entre as covariáveis e a variável outcome ­ preparação intestinal inadequada. As variáveis estatisticamente significativas foram incluídas num modelo de regressão logística binária e performance testada com a realização de curva ROC. Resultados: Incluímos 167 cápsulas do colon consecutivas. Sessenta e oito por cento (n = 114) eram do sexo feminino, com idade média de 64 anos. A principal indicação para cápsula do colon foi uma colonoscopia prévia incompleta, em 158 indivíduos (94.6%). As preparações intestinais em cápsula do colon foram classificadas como boas ou excelentes em 96 indivíduos (57.5%) e como inadequadas em 71 (42.5%), de acordo com a CC-CLEAR. As variáveis preparação cólica prévia inadequada [OR ajustado 41.72 (95% CI 12.57­138.57) valor p < 0.001]; uso crónico de laxante [OR ajustado 4.86 (95% CI 1.08­21.79) valor p = 0.039]; antidepressivo [OR ajustado 5.00 (95% CI 1.65­15.16) valor p = 0.004] e défice de mobilidade [OR ajustado 5.54 (95% CI 1.17­26.31) valor p = 0.031] foram independentemente associadas ao outcome, preparação intestinal inadequada, após o ajuste para o confundimento. O modelo apresentou um excelente poder discriminativo em relação ao outcome [AUC ROC 0.937 (CI95% 0.899­0.975) valor p < 0.001]. Conclusão: Uma preparação cólica prévia inadequada, o uso crónico de laxantes e antidepressivos e um défice de mobilidade são preditores de preparação intestinal inadequada em cápsula do cólon, de acordo com a CC-CLEAR. Estas 4 variáveis formam um modelo que permite a categorização, com excelente acuidade, de indivíduos com risco elevado para preparação intestinal inadequada em cápsula do colon, o que parece ser útil para uma otimização caso a caso do protocolo de preparação intestinal.

CC-CLEAR (Colon Capsule Cleansing Assessment and Report): the novel scale to evaluate the clinical impact of bowel preparation in capsule colonoscopy - a multicentric validation study.

BACKGROUND: Colon Capsule Cleansing Assessment and Report (CC-CLEAR) is a novel quantitative bowel preparation scale for colon capsule. AIM: The aim of this study is to validate the association between CC-CLEAR's classification and major CC outcomes: lesion detection rate, surveillance recommendations and post-CC endoscopic treatment. METHODS: Multicentric cohort of consecutive CCs. An expert's panel decided post-CC recommendations. Data included CC-CLEAR and Leighton-REX scales. Major CC outcomes were associated with the different cleansing grades. RESULTS: From 168 CC's included, findings were reported in 123 (73.2%), 67 (54.4%) of those being colorectal polyps. CC-CLEAR influenced CC's lesion detection (OR 1.25 95% IC [1.07-1.46], p-value .004) and polyp detection rate (OR 1.22 95% IC [1.04-1.43], p-value.014). Thirty-two (19%) post-CC colonoscopies were recommended, including 22 (68.75%) with at least one polypectomy. CC-CLEAR was associated with post-CC colonoscopy treatment (OR 1.40 95% IC [1.07-1.84], p-value .015). Regarding surveillance, CC-CLEAR influenced the decision for immediate CC repetition (OR 0.21 95% IC [0.12-0.36], p-value < .001) and the recommendation for CC in 3-5 years' time (OR 1.47 95% IC [1.50-1.86], p-value < .002). The Leighton-Rex scale was not correlated with major CC outcomes. CONCLUSION: CC-CLEAR impacts major CC outcomes: lesion detection, surveillance recommendations and post-CC endoscopic treatment.

RHEMITT score: Predicting the risk of mid gastrointestinal rebleeding after small bowel capsule endoscopy: A prospective validation.

BACKGROUND AND AIM: The RHEMITT score (Renal disease; Heart failure; Endoscopic findings; Major bleeding; Incomplete SBCE; Tobacco; Treatment by enteroscopy) was the first score to accurately predict the individual risk of small bowel rebleeding after capsule endoscopy (SBCE). The aim of the study is on the prospective validation of the RHEMITT score. METHODS: Cohort of consecutive patients with mid-gastrointestinal bleeding (MGIB) submitted to SBCE and followed prospectively, during at least 12 months, since 2017 until 2020. Rebleeding was defined as an overt bleeding event (melena or hematochezia) or a hemoglobin decrease of at least 2 g/dL. The RHEMITT score was calculated for each patient and the rebleeding rates compared. The performance of the score was tested by calculating the area under curve of the receiver operator characteristic curve. A rebleeding-free survival was assessed, corresponding to the period between the date of SBCE and the date of the first post-SBCE rebleeding event. RESULTS: We included 162 patients, 102 (62.9%) were female, with a mean age of 64 years old. The sensitivities and specificities of the score grades for predicting rebleeding were as following: for low-risk patients, 0% (0-10%) and 28.8% (21.1-36.5%); for intermediate-risk patients, 23.3% (8.2-38.4%) and 72% (64.3-79.7%); for high-risk patients, 76.7% (61.6-91.8%) and 99.2% (97.7-100%), corresponding to an area under curve of the receiver operator characteristic of 0.988 (P < 0.001). Kaplan-Meyer plots were statistically different according to the attributed risk (log-rank P value <0.001; Breslow-Wilcoxon P value <0.001). CONCLUSION: The RHEMITT score performed with excellent discriminative power in predicting rebleeding risk, and we herewith propose a surveillance of MGIB patients guided by the RHEMITT score.

Hyperbaric oxygen therapy for refractory pyoderma gangrenosum: a salvage treatment.

A 42-year-old woman with left-side ulcerative colitis (E2 - rectum to splenic flexure) was diagnosed with pyoderma gangrenosum (PG) on a persistent ulcerated wound with peripheral erythema, in the left leg's gemelar surface, associated with tenderness and pain. Due to incomplete response to wound care and oral prednisolone, treatment with infliximab was initiated. As PG remained unresponsive after 12 weeks, the patient was switched to adalimumab with concomitant oral prednisolone. Before the second induction dosage of adalimumab, the refractory PG complicated with a superinfection by Pseudomonas aeruginosa A course of wide spectrum antibiotic therapy, daily wound care including negative pressure bandages and a physiotherapy rehabilitation programme controlled the infection, but the pyoderma persisted non-healed, with visible deep muscle layers and tendons. We proposed hyperbaric oxygen therapy in addition to weekly adalimumab, achieving full remission of the PG and recovering of the left foot's function.

Does Perianal Disease Influence the Efficacy of Combination Therapy in Crohn's Disease?

BACKGROUND: Perianal disease is associated with a disabling course of Crohn's disease (CD). We aim to study the impact of perianal disease on CD remission rates, after a 1-year course of infliximab in combination therapy with azathioprine. METHODS: This was a retrospective, single-center cohort study, including consecutive CD patients on combination therapy, followed for 1 year since induction. The outcome variable was split into clinical and endoscopic remissions. The correlation toward the outcome variable was assessed with univariate and multivariate analysis and a survival assessment, using SPSS software. RESULTS: We assessed 74 CD patients, of whom 41 (55.4%) were female, with a mean age of 36 years. Thirty-nine percent of the patients presented perianal disease at diagnosis (n = 29). We documented 70.3% clinical and 47.2% endoscopic remissions. Several variables had statistical significance toward the outcomes (endoscopic and clinical remissions) in the univariate analysis. After adjusting for confoundment, patients with perianal disease presented an odds ratio (OR) of 0.201 for achieving endoscopic remission (CI: 0.054-0.75, p value 0.017) and an OR of 0.203 for achieving clinical remission (CI: 0.048-0.862, p value 0.031). Sixty-six patients (89.2%) presented an initial response to treatment, from whom, 20 (30.3%) exhibited at least 1 disease relapse (clinical and/or endoscopic). Patients with perianal disease presented higher probability of disease relapse, displaying statistically significant difference on Kaplan-Meier curves (Breslow p value 0.043). CONCLUSION: In the first year of combination therapy, perianal disease is associated with an 80% decrease in endoscopic and clinical remission rates and higher ratio of disease relapse.

Colon Capsule CLEansing Assessment and Report (CC-CLEAR): a new approach for evaluation of the quality of bowel preparation in capsule colonoscopy.

BACKGROUND AND AIMS: Current colon capsule (CC) cleansing grading scales rely on subjective parameters and lack proper interobserver agreement. We should strive for higher intra- and interobserver agreement for the evaluation of the cleansing quality of CCs. Here we sought to validate a new grading scale for the evaluation of CC cleansing. METHODS: For the new grading scale, named Colon Capsule CLEansing Assessment and Report (CC-CLEAR), the colon was divided in 3 segments: right-sided, transverse, and left-sided colon. Each segment was scored according to an estimation of the percentage of visualized mucosa (0, <50%; 1, 50%-75%; 2, >75%; 3, >90%). The overall cleansing classification was a sum of each segment score, grading between excellent (8-9), good (6-7), and inadequate (0-5). Any segment scoring ≤1 resulted in inadequate overall classification. Videos were reviewed and scored using CC-CLEAR and the Leighton-Rex grading scale by 2 experienced operators blinded to each other. Kendall's coefficient evaluated inter- and intraobserver agreement. RESULTS: We included 58 consecutive CCs, corresponding to 75.9% women, with a mean age of 65 years. Overall cleansing CC-CLEAR classifications were as follows: reader A, 22.4% (n = 13) excellent, 31% (n = 18) good, and 46.5% (n = 27) inadequate; and reader B, 24.1% (n = 14) excellent, 22.4% (n = 13) good, and 53.4% (n = 31) inadequate. CC-CLEAR interobserver agreement was superior to the Leighton-Rex scale (Kendall's W .911 vs .806, respectively; P < .01). The intraobserver agreement for CC-CLEAR was excellent for both readers (P > .01). CONCLUSIONS: CC-CLEAR is a new practical and reliable grading scale for the evaluation of bowel preparation quality using a CC, with excellent inter- and intraobserver agreement.

Transient elastography through controlled attenuated parameter assisting the stratification of cardiovascular disease risk in NAFLD patients.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. Transient elastography (Fibroscan ®), by assessing the controlled attenuation parameter (CAP), is a non-invasive method able to accurately assess the presence and the grade of steatosis. Its hypothetical role in stratifying cardiovascular (CV) risk is unknown. We aim to assess the role of transient elastography, namely the CAP value, in the stratification of CV risk. METHODS: Cohort, retrospective study, including consecutive NAFLD patients that underwent Fibroscan®. Patients were followed at least one year. The correlation towards the outcome variable (cardiovascular event) was assessed with univariate and multivariate analysis. RESULTS: We included 96 NAFLD patients, 64 (66.7%) women, with a mean age of 48.9 years-old. Fifteen (15.6%) patients presented a cardiovascular event during follow-up. The statistically significant variables associated with cardiovascular event were introduced in a multivariable binary logistic regression model according to clinical importance. The following variables kept a statistically significant independent association with cardiovascular event: CAP > 295 dB/m (OR 8.661 CI 95% [1.119-67.028]; p value 0.039); type 2 diabetes mellitus (OR 20.236 CI 95% [2.815-145.461]; p value 0.003); dyslipidaemia (OR 14.647 CI 95% [1.261-170.189]; p value 0.032) and smoking (OR 8.946 CI 95% [1.347-59.431]; p value 0.023). CONCLUSION: A CAP value above 295 dB/m independently increased the incidence of CV events up to 8-times. Transient elastography, through CAP, is a safe and cost-effective method to evaluate NAFLD, and should be considered in the stratification of CV risk.

Percutaneous endoscopic gastrostomy: dealing with the issue of dislodgement.

Introduction: Percutaneous Endoscopic Gastrostomy (PEG) is accepted as an efficient method to provide long-term enteral nutrition. PEG accidental dislodgement (device exteriorization confirmed by expert evaluation) rate is high and can lead to major morbidity.Objective: To identify independent risk factors for PEG accidental dislodgement.Methods: Retrospective, single-center study, including consecutive patients submitted to PEG procedure, for 38 consecutive months. Every patient had 12 months minimum follow-up after PEG placement. Univariate analysis selected variables with at least marginal association (p < .15) with the outcome variable, PEG dislodgement, which were included in a logistic regression multivariate model. Discriminative power was assessed using area under curve (AUC) of the receiver operating curve (ROC).Results: We included 164 patients, 67.7% (111) were female, mean age was 81 years. We report 59 (36%) PEG dislodgements, of which 13 (7.9%) corresponded to early dislodgements. The variables with marginal association were hypoalbuminemia (p = .095); living at home (p = .049); living in a nursing home (p = .074); cerebrovascular disease (CVD) (p = .028); weight change of more than 5 kg, either increase or decrease (p = .001); psychomotor agitation (p < .001); distance inner bumper-abdominal wall (p = .034) and irregular appointment follow-up (p = .149). At logistic multivariate regression, the significant variables after model adjustment were CVD OR 4.8 (CI 95% 2.0-11.8), weight change OR 4.7 (CI 95%1.6-13.9) and psychomotor agitation OR 18.5 (CI 95% 5.2-65.6), with excellent discriminative power (AUC ROC 0.797 [CI95% 0.719-0.875]).Conclusion: PEG is a common procedure and accidental dislodgement is a frequent complication. CVD, psychomotor agitation and weight change >5 kg increase the risk of this complication and should be seriously considered when establishing patients' individual care requirements.

RHEMITT Score: Predicting the Risk of Rebleeding for Patients with Mid-Gastrointestinal Bleeding Submitted to Small Bowel Capsule Endoscopy.

INTRODUCTION: Small bowel capsule endoscopy (SBCE) is the gold standard for mid-gastrointestinal bleeding (MGIB). No score has been developed to predict the risk of small bowel rebleeding after SBCE. OBJECTIVE: Creating a predictive small bowel rebleeding risk score for MGIB, after initial SBCE. METHODS: Retrospective, single center study, including SBCEs for MGIB, from June 2006 to October 2016. The minimum follow-up was 12 months. Univariate analysis and a multivariable Cox regression model tested the association with rebleeding. Statistically significant variables were used to compute the score. The score's accuracy was tested through a receiver operating characteristic (ROC) curve. A classification tree identified risk groups. For internal validation, we performed a 5-fold cross validation. RESULTS: We assessed 357 SBCEs for MGIB, of which 88 (24.6%) presented rebleeding during follow-up. Seven variables were used to compute a risk-predicting score - the RHEMITT score - namely, renal disease; heart failure; endoscopic capsule P1/P2 lesions; major bleeding; incomplete capsule; tobacco consumption; and endoscopic treatment. The score presented good accuracy toward the outcome (area under the curve ROC 0.842, 95% CI 0.757-0.927). We established 3 rebleeding risk groups: low (0-3 points); intermediate (4-10 points); and high (+11 points). CONCLUSION: A new MGIB score, named RHEMITT, accurately anticipates the individual risk of small bowel rebleeding after initial SBCE.

How should we select suspected Crohn's disease patients for capsule enteroscopy?

Background: In suspected Crohn's disease (CD), non-diagnostic ileocolonoscopies are often followed by small bowel capsule endoscopy (SBCE). Adequate pre-selection of patients for SBCE is a key to optimize allocation of resources. We aimed to establish a rational approach for the CD diagnostic workflow, based on biochemical profile of patients with suspected CD, targeting an optimization of patients' selection for SBCE. Methods: Multicenter cohort study includes consecutive patients with suspected undergoing SBCE after non-diagnostic ileocolonoscopy. Minimum follow-up period after the capsule enteroscopy was six months. The outcome was confirmation of CD diagnosis. Univariate analysis and logistic regression were performed. Results: In included 220 patients, 62.3% of women were with a mean age of 41 years [26-54]. A confirmed diagnosis of CD was established in 98 patients (44.5%). The initial univariate analysis identified variables above the threshold of marginal statistical association toward CD diagnosis (p < .15). The regression model identified high CRP levels (OR 1.028 p = .128) and low serum Iron (OR 0.990 p = .025) as the independent variables with consistent correlation with CD diagnosis. Those two variables present a suitable discriminative power (AUC = 0.669, p < .001) for the diagnosis of CD. Conclusion: In suspected CD, low serum iron and elevated CRP had a statistically significant association with CD diagnosis, being helpful to identify patients with higher CD probability before SBCE. However, the lack of a proper validation of the model leads us to currently recommend SBCE to all patients with suspected CD and negative ileocolonoscopy, as no specific biochemical profile can be used to confidently exclude small bowel CD.