Background Bowel preparation represents a significant issue to high-quality colonoscopy. Oral mannitol requires a single dose, is of low volume, and has a pleasant taste and rapid action. Aims This SATISFACTION study compared single-dose (same day) oral mannitol 100 g/750 mL with standard split-dose PEG-ASC2 L (MoviPrep®). Methods The primary endpoint was the proportion of patients with adequate bowel cleansing. Secondary endpoints included efficacy (adenoma detection rate, caecal intubation rate, time of evacuation), safety (intestinal gases concentration, haemato-chemical parameters, adverse events), and patient satisfaction. Results The study included 703 patients (352 treated with mannitol and 351 with PEG-ASC). Mannitol was not inferior to PEG-ASC for the primary endpoint (91.1 % and 95.5 %, respectively; p-value for the non-inferiority =0.0131). There was no significant difference for secondary efficacy endpoints. The acceptability profile was significantly better in the mannitol group for ease of use, taste, and willingness to reuse (p < 0.0001 for all). The concentration of intestinal gases (H2, CH4) was similar between groups and well below those potentially critical. Conclusions The SATISFACTION study indicated that low-volume, single-dose mannitol may satisfy an unmet clinical need since it was more acceptable to the patient and not inferior to the split-dose PEG-ASC for bowel cleansing efficacy.
Abstract This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel‐group phase II–III study investigated this issue. The phase II dose‐finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split‐dose 2 L polyethylene glycol (PEG)‐Asc preparation (2 L PEG‐Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG‐Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019‐002856‐18).
Universita degli Studi di Milano, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy; Istituto Europeo di Oncologia, Italy; Centro di Riferimento Oncologico IRCCS, Italy; Fondazione Poliambulanza Istituto Ospedaliero, Italy; Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Italy; Universita Cattolica del Sacro Cuore, Italy; Ente Ospedaliero Valduce, Italy; Aziende Socio Sanitaria Territoriale Rhodense, Italy; NTC, Italy; Hopital Edouard Herriot, France; Istituto Auxologico Italiano Istituto di Ricovero e Cura a Carattere Scientifico, Italy; Ospedale Santa Chiara di Trento, Italy; Yaroslav Regional Cancer Center, Russian Federation; IRCCS Sacro Cuore Don Calabria, Italy; Ospedale Papa Giovanni XXIII, Italy; Universita degli Studi di Brescia, Italy; Irkutskij gosudarstvennyj universitet, Russian Federation; Centre Hospitalier Regional Universitaire de Montpellier, France; State Scientific Center of Coloproctology named after A.N.
Primary Epstein-Barr virus (EBV) infection may present with self-limiting abdominal involvement, characterized by hepatitis with mild elevation of aminotransferases, splenomegaly, and rarely with acute acalculous cholecystitis (AAC). Usually, treatment of EBV related AAC is symptomatic, without the need for surgery. Here, we describe a severe case of AAC occurring as the first manifestation of infectious mononucleosis in a young adult woman, receiving treatment with interleukin 6 receptor (IL-6r) inhibitor for rheumatoid arthritis (RA); moreover, we have performed a review of the literature on EBV-related AAC.
ABSTRACT Posterior reversible encephalopathy syndrome is a rare syndrome characterized by brain edema and neurological symptoms, often resulting from several drugs. Treatment is based on discontinuation, and diagnosis is thus essential. Only 13 cases of posterior reversible encephalopathy syndrome have been reported in inflammatory bowel diseases, and we present the first after azathioprine in adults. A 56-year-old patient with active ulcerative colitis was found unconscious 5 days after the institution of azathioprine. Right-sided hemiplegia was found after the patient regained consciousness. Magnetic resonance imaging showed altered signal associated with diffusion restriction in the occipital lobe and cerebral vasogenic edema. Complete regression of neurological signs occurred after azathioprine discontinuation.
Background: The main goal in the treatment of ulcerative colitis (UC) is to achieve mucosal healing. Despite being unvalidated, the most widely used scoring system is the Mayo endoscopic subscore (MES). However, the recently established and validated Ulcerative Colitis Endoscopic Index of Severity (UCEIS) represents an interesting alternative method in assessing endoscopic disease activity. Objective: Due to a lack of reliable prognostic factors, the aim of this study was to investigate the diagnostic accuracy of the UCEIS and the MES, in predicting response to biological therapy and the need for colectomy. Methods: We conducted a retrospective, uncontrolled, single-center study on UC patients with endoscopically active disease even with concomitant conventional and/or biological therapy, who had already started or had been changed a biological treatment. Results: Sixty-one UC patients were enrolled. At baseline, 71% were naive to biological therapies and 41% had an extensive colitis. At control time (median time of 11.5 months), MES and UCEIS scores significantly decreased from those at baseline (from 2.6 to 1.8 and 5 to 3.2, respectively, p < 0.001). UCEIS, but not MES, was found to be significantly associated with unresponsiveness to therapy (p = 0.040). Moreover, when UCEIS was ≥7, all patients underwent colectomy after a median time of 5 months (p < 0.001). Conclusion: UCEIS may be superior to MES because of its accuracy and predictive role. Therefore, UCEIS should be considered for use in daily clinical practice.
Study Objective: To evaluate the incidence, risk factors. and treatment of colorectal anastomotic stenosis in patients who undergo rectosigmoid resection for deep infiltrating endometriosis (DIE). Design: Retrospective analysis of a prospective database (Canadian Task Force classification III). Setting: Public medical center. Patients: All women who underwent laparoscopic rectosigmoid resections for DIE at our hospital between January 2002 and December 2016. Intervention: All patients were evaluated clinically and endoscopically at 1 month and 3 months after bowel resection. Stenosis was defined as a lack of passage through the anastomosis of a 12-mm proctoscope. Symptomatic stenosis was defined as the presence of endoscopically confirmed stricture accompanied by at least 2 of the following symptoms: constipation, need to push, tenesmus, and ribbon stools. Only patients with symptomatic stenosis were studied. Demographic data, surgical techniques, and postoperative complications were recorded prospectively. Treatments and outcomes of anastomotic symptomatic strictures were analyzed. Measurements and Main Results: A total of 1643 patients underwent laparoscopic rectosigmoid resection at our hospital between January 2002 and December 2016. Among these, 104 patients (6.3%) presented with symptomatic anastomotic stenosis. The median patient age was 27 years (range, 23-44 years), and the median interval between diagnosis and the onset of symptomatic stenosis was 57 days (range, 21-64 days). The only statistically significant predictors of anastomotic stenosis were the presence of ileostomy (p = .01) and previous pelvic surgery (p = .002). Treatment of choice was always conservative. Of the 104 patients in the study cohort. 90 (86.5%) underwent 3 endoscopic dilatations. No patient required reoperation. Conclusion: The anastomotic stricture is a recognized complication in patients following intestinal resection for DIE. and protective ileostomy is the sole modifiable factor related to anastomotic stenosis. Endoscopic dilatation is a valid option to treat this complication. (C) 2018 AAGL. All rights reserved.
Up to one-third of fertile-age women with severe endometriosis suffer from colonic involvement. Transvaginal ultrasonography has become a first-line diagnostic tool for the study of the pelvis and more specifically for the diagnosis of pelvic endometriosis. Accuracy of pelvic ultrasound for deep endometriosis increases with operator experience, but the difficulties in the differential diagnosis with diseases that can afflict the bowel tract remain a challenge. We reviewed noteworthy cases referred for secondary level diagnosis suspected of bowel endometriosis in which the subsequent ultrasound led to an alternative diagnosis. This case series aims to highlight awareness for both experts and less-experienced operators the possible differential diagnoses of bowel lesions that initially resemble endometriosis.
Biological drugs represent the best choice for treating patients with moderate to severe ulcerative colitis (UC). About 60% of patients fail to achieve clinical and endoscopic remission and about 20% undergo colectomy. The ulcerative colitis Endoscopic Index of Severity (UCEIS) is a new validated score but the Mayo Endoscopic Subscore (MES) still represents the most used index. The aim of this study was to evaluate the predictive role of UCEIS and MES in identifying patients not responding to biological therapy and their need for surgery. We retrospectively evaluated patients enrolled between 2014 and 2018. Endoscopic disease activity was assessed with MES and UCEIS at baseline and at Week 48. Unresponsiveness was defined as UCEIS ≥ 2. Statistical analysis included Fisher exact test, receiver-operator characteristic (ROC) curves and log-rank test for Kaplan–Meier plots. A p-value of <0.05 was considered significant. Sixty-one patients were included (28 infliximab, 10 adalimumab, 20 golimumab, 3 vedolizumab). Forty-three patients (70.5%) were unresponsive to therapy. The UCEIS, unlike the MES, was found to be significantly associated with unresponsiveness (p = 0.003 vs. p = 0.389). The area under the ROC curves (AUROC) of UCEIS were 0.58, 0.69 and 0.60, using cut-off value of 7, 6 and 5. Specificity was 94% and sensitivity was 44% using cut-off value of 6. The AUROC of MES was 0.57 with specificity and sensitivity of 50% and 65%, respectively, using a cut-off value of 3. Among unresponsive patients, 13 (30.2%) underwent colectomy for treatment failure. Twelve (92.3%) patients were MES = 3 at baseline with an overall colectomy-free survival rate significantly lower compared with MES = 2 (p = 0.007). According to the UCEIS at baseline, 6 patients (46.2%) with UCEIS 5-6 and 7 (53.8%) with UCEIS ≥ 7 needed for surgery. When the UCEIS ≥ 7, 100% of patients underwent colectomy (log-rank test for UCEIS p < 0.001). Colectomy-free survival rates according to the UCEIS score (all patients with MES = 3 at baseline). ROC curves of UCEIS (cut-off value of 6) vs. MES (cut-off value of 3) in predicting response to treatment. The UCEIS score, compared with MES, better predict UC patients unresponsive to biological therapy. It is also useful for identifying patients needing colectomy.
•GUT microbiota alterations have a role in gastrointestinal carcinogenesis.•GUT microbiota modulates the activity and the toxicity of several chemotherapy agents.•The manipulation of GUT microbiota could improve the chemotherapy efficacy.•Toxicity from chemotherapy could be reduced through GUT microbiota manipulation.
Brunner’s gland hamartoma (BGH) is an uncommon benign tumor arising from alkaline-based mucin-secreting glands of the duodenum. These lesions are typically discovered incidentally during upper gastrointestinal endoscopy or radiological diagnostics, even though they can eventually lead (in the case of increasing size) to obstructive or hemorrhagic symptoms. We report the case of a 67-year-old Caucasian man with two episodes of melena and epigastric pain during the last month. Esophagogastroduodenoscopy revealed a large pedunculated and eroded polyp inside the antrum with a 2-cm-long stalk arising from the anterior wall of the duodenal bulb. Endoscopic ultrasonography showed a submucosal lesion with homogeneous hyperechoic parietal thickening and some central gaps. The muscularis was undamaged. No lymphadenopathy was observed. We performed an en bloc endoscopic resection of the polyp. The size of the whole piece was approximately 6 × 3 × 2 cm, pseudocapsulated and tough in consistency. In the case presented, the en bloc endoscopic removal was successful despite the size of the tumor.
BACKGROUND: Inflammatory bowel disease (IBD) represents a group of chronic conditions characterized by elevated costs. Over the last years, also a considerable healthcare burden associated with IBD has emerged, due to an increasing use of biological drugs and hospitalization costs. Despite the creation of local or regional databases, data regarding healthcare expenditure are lacking in Italy.AIM: To evaluate the treatment cost (biological drugs and hospitalizations) for patients with ulcerative colitis (UC) or Crohn’s disease (CD) treated with biological drugs.METHODS: Disease severity was evaluated by clinical scores (partial Mayo score and Harvey Bradshaw Index). We analyzed retrospectively patients treated with biologics referred to our IBD Unit between May 2015-April 2016 who underwent at least six months of follow-up (last visit October 2016). We calculated a mean cost per month of treatment for each patient. We also investigated the presence of any correlation between the monthly cost of treatment and demographic or clinical variables.RESULTS: We enrolled 142 patients (52 UC, mean age 44.3 years, male 40.4%; 90 CD, mean age 38.8 years, male 56.7%). About half of CD patients (48.9%) underwent previous intestinal surgery. The disease severity was higher in UC group vs CD group. In UC group infliximab was the most prescribed biologic (51.9%), followed by golimumab (26.9%) and adalimumab (21.2%). While CD patients were treated with adalimumab in 54.4% and infliximab in 45.6%. The mean monthly cost of treatment was € 1,235.41 ± 358.38 for UC and € 1,148.92 ± 337.36 for CD (p = 0.16). In both groups expenditure due to biologics amounts for more than 80%. We found a correlation between costs and disease activity (UC: p < 0.01; CD: p < 0.01).CONCLUSION: The main cost is due to biological drugs, but patients enrolled were the most severe in comparison to the whole IBD population under conventional therapy. As no cost differences were found between biologic drugs and the way of administration (intravenous or subcutaneous), the therapeutic choice should be driven by clinical reasons and not only economic ones.
BACKGROUND:Pepsin plays a role in gastroesophageal reflux (GER). Aims of this study were to verify if pepsin could be the cause of frequent bronchial exacerbations and to check if the persistence of chronic respiratory symptoms were correlated with pre-existing respiratory diseases.METHODS:From January to May 2016, 42 patients underwent a diagnostic bronchoscopy. All patients had a history of at least one bronchial exacerbation during the previous year. Bronchial lavage fluid specimens were obtained. A semiquantitative assessment of pepsin in the samples was carried out based on the intensity of the test sample.RESULTS:Pepsin was present in 37 patients (88%), but in patients with bronchial asthma and chronic obstructive pulmonary disease (COPD), the finding of pepsin in the bronchoalveolar fluid was 100%. There was a strong positive statistical correlation between pepsin detection and radiological signs of GER (ρ=0.662), and between pepsin detection and diagnosis (ρ=0.682). No correlation was found between the bacteriology and the presence of pepsin in the airways (ρ=0.006).CONCLUSIONS:The presence of pepsin in the airways shows the occurrence of reflux. The persistence of respiratory symptoms by at least 2 months suggest an endoscopic bronchial examination. This straightforward test confirms the cause possible irritation of the airways and may prevent further diagnostic tests, such as an EGD or pH monitoring esophageal.