OBJECTIVE:This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND:Recently, a new antimesenteric, functional, ...end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS:Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpointendoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpointsclinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS:In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER P < 0.001, odds ratio (OR) 5.91. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS:This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.
Sarcopenia represents a major health burden in industrialized country by reducing substantially the quality of life. Indeed, it is characterized by a progressive and generalized loss of muscle mass ...and function, leading to an increased risk of adverse outcomes and hospitalizations. Several factors are involved in the pathogenesis of sarcopenia, such as aging, inflammation, mitochondrial dysfunction, and insulin resistance. Recently, it has been reported that more than one third of inflammatory bowel disease (IBD) patients suffered from sarcopenia. Notably, the role of gut microbiota (GM) in developing muscle failure in IBD patient is a matter of increasing interest. It has been hypothesized that gut dysbiosis, that typically characterizes IBD, might alter the immune response and host metabolism, promoting a low-grade inflammation status able to up-regulate several molecular pathways related to sarcopenia. Therefore, we aim to describe the basis of IBD-related sarcopenia and provide the rationale for new potential therapeutic targets that may regulate the gut-muscle axis in IBD patients.
The chronic inflammation of Crohn's disease is caused, at least in part, by repression of TGF-β1 signaling, which is caused by high levels of SMAD7. This trial shows that mongersen, an antisense ...inhibitor of
SMAD7
mRNA, induces disease remission in some persons.
Crohn’s disease is a chronic inflammatory illness that primarily affects the terminal ileum and right colon. Crohn’s disease–related inflammation is segmental and transmural, leading to various degrees of tissue damage.
1
At disease onset, most patients have inflammatory lesions, which become predominantly strictures or penetrating lesions over time.
2
,
3
Mucosal healing can be promoted with the use of immunosuppressive drugs and anti–tumor necrosis factor
α
(TNF-
α
) antibodies; however, more than one third of patients do not have a response to these therapies. The efficacy of these drugs may also diminish over time, and they can increase a patient’s risk . . .
Osteoporosis is characterized by an alteration of bone microstructure with a decreased bone mineral density, leading to the incidence of fragility fractures. Around 200 million people are affected by ...osteoporosis, representing a major health burden worldwide. Several factors are involved in the pathogenesis of osteoporosis. Today, altered intestinal homeostasis is being investigated as a potential additional risk factor for reduced bone health and, therefore, as a novel potential therapeutic target. The intestinal microflora influences osteoclasts' activity by regulating the serum levels of IGF-1, while also acting on the intestinal absorption of calcium. It is therefore not surprising that gut dysbiosis impacts bone health. Microbiota alterations affect the OPG/RANKL pathway in osteoclasts, and are correlated with reduced bone strength and quality. In this context, it has been hypothesized that dietary supplements, prebiotics, and probiotics contribute to the intestinal microecological balance that is important for bone health. The aim of the present comprehensive review is to describe the state of the art on the role of dietary supplements and probiotics as therapeutic agents for bone health regulation and osteoporosis, through gut microbiota modulation.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Background & Aims Few data are available on effects of biologic therapies in patients more than 65 years old with inflammatory bowel disease (IBD). We evaluated the risk and benefits of therapy with ...tumor necrosis factor (TNF) inhibitors in these patients. Methods We collected data from patients with IBD treated with infliximab (n = 2475) and adalimumab (n = 604) from 2000 to 2009 at 16 tertiary centers. Ninety-five patients (3%) were more than 65 years old (52 men; 37 with ulcerative colitis and 58 with Crohn's disease; 78 treated with infliximab and 17 with adalimumab). The control group comprised 190 patients 65 years old or younger who were treated with both biologics and 190 patients older than 65 years who were treated with other drugs. The primary end points were severe infection, cancer, or death. Results Among patients more than 65 years old who received infliximab and adalimumab, 11% developed severe infections, 3% developed neoplasms, and 10% died. No variable was associated with severe infection or death. Among control patients more than 65 years old, 0.5% developed severe infections, 2% developed cancer, and 2% died. Among control patients less than 65 years old, 2.6% developed severe infections, none developed tumors, and 1% died. Conclusions Patients older than 65 years treated with TNF inhibitors for IBD have a high rate of severe infections and mortality compared with younger patients or patients of the same age that did not receive these therapeutics. The effects of anti-TNF agents in older patients with IBD should be more thoroughly investigated, because these patients have higher mortality related to hospitalization than younger patients.
Patients with ulcerative colitis (UC) receiving immunosuppressive drugs are at substantial risk of colectomy. We aimed to assess the risk of postoperative complications of tofacitinib exposure before ...colectomy in comparison with biologics.
A multicenter, retrospective, observational study was conducted in patients with UC who underwent total colectomy for medically refractory disease, exposed to tofacitinib or a biologic before surgery. Primary outcome was the occurrence of any complication within 30 (early) and 90 (late) days after surgery. Secondary outcomes were the occurrence of infections, sepsis, surgical site complications, venous thromboembolic events (VTE), hospital readmissions, and redo surgery within the same timepoints.
Three hundred one patients (64 tofacitinib, 162 anti-tumor necrosis factor-α agents, 54 vedolizumab, and 21 ustekinumab) were included. No significant differences were reported in any outcome, except for a higher rate of early VTE with anti-tumor necrosis factor-α agents ( P = 0.047) and of late VTE with vedolizumab ( P = 0.03). In the multivariate analysis, drug class was not associated with a higher risk of any early and late complications. Urgent colectomy increased the risk of any early (odds ratio OR 1.92, 95% confidence interval CI 1.06-3.48) complications, early hospital readmission (OR 4.79, 95% CI 1.12-20.58), and early redo surgery (OR 7.49, 95% CI 1.17-47.85). A high steroid dose increased the risk of any early complications (OR 1.96, 95% CI 1.08-3.57), early surgical site complications (OR 2.03, 95% CI 1.01-4.09), and early redo surgery (OR 7.52, 95% CI 1.42-39.82). Laparoscopic surgery decreased the risk of any early complications (OR 0.54, 95% CI 0.29-1.00), early infections (OR 0.39, 95% CI 0.18-0.85), and late hospital readmissions (OR 0.34, 95% CI 0.12-1.00).
Preoperative tofacitinib treatment demonstrated a postoperative safety profile comparable with biologics in patients with UC undergoing colectomy.
Purpose
Inadequate oral intake may play an important role in the onset of malnutrition in patients with Crohn’s disease (CD). The aims of this cross-sectional study were: (1) to compare dietary ...intake in clinically active and quiescent CD patients, and (2) to assess patients’ nutritional adequacy relative to the dietary reference values (DRVs) for the Italian population using LARN (Livelli di Assunzione di Riferimento di Nutrienti ed energia per la popolazione italiana).
Methods
Patients aged between 18 and 65 years with a diagnosis of CD were recruited
.
All participants underwent anthropometry and were instructed to fill in a 3-day food record. Disease activity was clinically defined using the Crohn’s disease activity index (CDAI).
Results
Overall, 117 patients, 71 males and 46 females, with a mean age of 39.6 ± 13.8 years and a mean body weight of 65.4 ± 11.8 kg, were ultimately included. Our findings showed that the amount of nutrients was similar between patients with active and quiescent disease. The mean intake of macronutrients was adequate, except for fiber, while dietary micronutrients were insufficient. Median intakes of sodium, phosphorus, and fluorine met LARN recommendations in both sexes, and the DRVs were accomplished by many patients (53/117; 104/117 and 98/117, respectively). Interestingly, dietary amounts of iron and zinc were barely acceptable in males but not in females. However, a few of the patients (< 15) met the LARN for potassium, calcium, and magnesium, regardless of sex and CDAI. With respect to vitamins, no relevant difference was found between the active and quiescent groups, and none of them met recommended values in both sexes.
Conclusions
This study showed that the assessment of dietary intake can be crucial for optimizing dietary intervention with focused nutrition counseling, to improve nutritional status in CD patients.
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DOBA, EMUNI, FIS, FSPLJ, FZAB, GEOZS, GIS, IJS, IMTLJ, IZUM, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, SIK, UILJ, UKNU, UL, UM, UPUK, VKSCE, VSZLJ, ZAGLJ
Background:
While mucosal healing (MH) and transmural healing (TH) predict relevant clinical outcomes in Crohn’s disease (CD), little is known about the real significance and clinical impact of deep ...remission (DR).
Objectives:
To better explore the concept of DR, toward a direct correlation between MH, TH, and biomarkers.
Design:
Real-world observational longitudinal study to evaluate the rate of clinical remission (CR), MH and TH, and the fecal calprotectin (FC)/C-reactive protein (CRP) levels in all consecutive CD patients on biologics.
Methods:
A receiver operating characteristic (ROC) curve was constructed to define the best FC and CRP cut-offs associated with MH and TH. Finally, patients achieving CR, MH, and TH, in association with the target FC/CRP values, were considered in DR.
Results:
Among 118 CD patients, CR, MH, and TH were achieved in 62.7, 44.1, and 32.2%, respectively. After 2 years, the mean FC levels decreased from 494 ± 15.4 μg/g to 260 ± 354.9 μg/g (p < 0.01). Using the ROC curve analysis, an FC cut-off value of 94 μg/g was associated with both MH sensitivity: 94.2%, specificity: 84.8%, positive predictive value (PPV): 83.05%, negative predictive value (NPV): 94.92%, area under the curve (AUC): 0.95 and TH (sensitivity: 92.1%, specificity: 70%, PPV: 64.4%, NPV: 94.9%, AUC: 0.88). CRP < 5 mg/L was associated with both MH (sensitivity: 96.1%, specificity: 62.1%, PPV: 66.7%, NPV: 95.35%, AUC: 0.85) and TH (sensitivity: 97.4%, specificity: 52.5%, PPV: 52%, NPV: 95.35%, AUC: 0.78). When considering CD patients with concomitant CR, MH, and TH associated with an FC < 94 μg/g and CRP < 5 mg/L, this association was found identified in 33 patients (27.9%).
Conclusion:
An FC < 94 μg/g and a normal CRP are associated with CR, MH, and TH and could be included in the definition of DR in association. So by definition, DR could be achieved in approximately 30% of CD patients during maintenance treatment with biologics.
(1) Background: Sarcopenia has a high incidence in Crohn’s disease (CD) with considerable heterogeneity among ethnicities and variable impact on clinical outcomes. Aim: to assess the impact of ...sarcopenia on clinical outcomes in a cohort of Caucasian patients with active CD undergoing CT-enterography (CTE) for clinical assessment. We further investigated the prevalence of sarcopenia and its predictors. (2) Methods: Caucasian CD patients with moderate−severe clinical activity, who underwent CTE in an emergency setting, were retrospectively recruited. The skeletal muscle index (SMI) at the third lumbar vertebra was used to detect sarcopenia in the early stages. Clinical malnutrition was defined according to global clinical nutrition criteria. Clinical outcomes included the rate of surgery and infections within one year. (3) Results: A total of 63 CD patients (34 M; aged 44 ± 17 years) were recruited, and 48 patients (68.3%) were sarcopenic. Malnutrition occurred in 28 patients (44.4%) with a significant correlation between body mass index (BMI) and sarcopenia (r = 0.5, p < 0.001). The overall rate of surgery was 33%, without a significant difference between sarcopenic and non-sarcopenic (p = 0.41). The rate of infection in patients with sarcopenia was significantly higher than in non-sarcopenic (42%vs15%, p = 0.03). BMI (OR 0.73,95%, CI 0.57−0.93) and extraintestinal manifestations (EIM) (OR 19.2 95%, CI 1.05−349.1) were predictive of sarcopenia (p < 0.05). (4) Conclusions: Sarcopenia was associated with an increased rate of infections, and it was observed in 68.3% of the Caucasian cohort with active CD.
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