Elective Colectomy in a Patient with Active Ulcerative Colitis and Metastatic Melanoma Enabling Successful Treatment with Immune Checkpoint Inhibitors.
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SUBMITTER: Perdigoto AL
PROVIDER: S-EPMC7993656 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Ulcerative colitis (UC) can be treated with surgery or medications. Patients often must choose between long-term immunosuppressant therapy or total colectomy. Whether one of these treatment approaches has a mortality benefit is uncertain.To determine whether patients with advanced UC treated with elective colectomy have improved survival compared with those treated with medical therapy.Retrospective matched cohort study.Data from all 50 states for Medicaid beneficiaries (2000 to 2005), Medicare beneficiaries (2006 to 2011), and dual-eligible persons (2000 to 2011).830 patients with UC pursuing elective colectomy and 7541 matched patients with UC pursuing medical therapy.The primary outcome was time to death. Cox proportional hazards models were used to compare the survival of patients with advanced UC treated with elective colectomy or medical therapy. The models controlled for significant comorbid conditions through matched and adjusted analysis.The mortality rates associated with elective surgery and medical therapy were 34 and 54 deaths per 1000 person-years, respectively. Elective colectomy was associated with improved survival compared with long-term medical therapy (adjusted hazard ratio [HR], 0.67 [95% CI, 0.52 to 0.87]), although this result did not remain statistically significant in all sensitivity analyses. Post hoc analysis by age group showed improved survival with surgery in patients aged 50 years or older with advanced UC (HR, 0.60 [CI, 0.45 to 0.79]; P = 0.032 for age-by-treatment interaction).Retrospective nonrandomized analysis is subject to residual confounding. The source cohort was derived from different databases throughout the study. Sensitivity and secondary analyses had reduced statistical power.Elective colectomy seemed to be associated with improved survival relative to medical therapy among patients aged 50 years or older with advanced UC.National Institutes of Health and Agency for Healthcare Research and Quality.
| S-EPMC4925099 | biostudies-literature
Project description: Not available
| S-EPMC10904456 | biostudies-literature
Project description:BackgroundUlcerative colitis (UC) patients failing medical management require colectomy. This study compares risk estimates for predictors of postoperative complication derived from administrative data against that of chart review and evaluates the accuracy of administrative coding for this population.MethodsHospital administrative databases were used to identify adults with UC undergoing colectomy from 1996-2007. Medical charts were reviewed and regression analyses comparing chart versus administrative data were performed to assess the effect of age, emergent operation, and Charlson comorbidities on the occurrence of postoperative complications. Sensitivity, specificity, and positive/negative predictive values of administrative coding for identifying the study population, Charlson comorbidities, and postoperative complications were assessed.ResultsCompared to chart review, administrative data estimated a higher magnitude of effect for emergent admission (OR 2.52 [95% CI: 1.80-3.52] versus 1.49 [1.06-2.09]) and Charlson comorbidities (OR 2.91 [1.86-4.56] versus 1.50 [1.05-2.15]) as predictors of postoperative complications. Administrative data correctly identified UC and colectomy in 85.9% of cases. The administrative database was 37% sensitive in identifying patients with???1Charlson comorbidity. Restricting analysis to active comorbidities increased the sensitivity to 63%. The sensitivity of identifying patients with at least one postoperative complication was 68%; restricting analysis to more severe complications improved the sensitivity to 84%.ConclusionsAdministrative data identified the same risk factors for postoperative complications as chart review, but overestimated the magnitude of risk. This discrepancy may be explained by coding inaccuracies that selectively identifying the most serious complications and comorbidities.
| S-EPMC3432603 | biostudies-literature
Project description:Ulcerative colitis (UC) is a complex chronic pathological condition of the gut in which microbiota targeted treatment, such as fecal microbiota transplantation (FMT), has shown an encouraging effect. The aim of the present study was to investigate the efficacy and safety of FMT in patients with mild or moderate UC. A single-center, open-label study was designed, including 47 patients with mild or moderate active UC who received three treatments of fresh FMT via colonic transendoscopic enteral tubing within 1 week. The inflammatory bowel disease questionnaire, partial Mayo scores, colonoscopy, erythrocyte sedimentation rate, C-reactive protein level and procalcitoin values were used to assess the efficacy of FMT and alteration in gut microbiota was detected by 16S ribosomal RNA-sequencing. Before FMT, microbiota Faecalibacterium prausnitzii (F. prausnitzii) levels were significantly decreased in patients with UC compared with healthy donors (P<0.01). At 4 weeks post-FMT, F. prausnitzii levels were significantly increased (P<0.05), and the Mayo score was significantly decreased (1.91±1.07 at baseline vs. 4.02±1.47 at week 4; P<0.001) in patients with UC compared with healthy donors. Steroid-free clinical responses were reported in 37 patients (84.1%), and steroid-free clinical remission was achieved in 31 patients (70.5%) at week 4 post-FMT, however, steroid-free remission was not achieved in any patient. No adverse events were reported in 41 (93.2%) patients after FMT or during the 12-week follow-up. Shannon's diversity index and Chao1 estimator were also improved in patients with UC receiving FMT. In conclusion, the results of the present study suggested that FMT resulted in clinical remission in patients with mild to moderate UC, and that the remission may be associated with significant alterations to the intestinal microbiota of patients with UC. Furthermore, F. prausnitzii may serve as a diagnostic and therapeutic biomarker for the use of FMT in UC.
| S-EPMC7086197 | biostudies-literature
Project description:IntroductionThe Center for Medicare and Medicaid Services established 30-day readmission rate as a key metric in measuring high-value, cost-conscious care; therefore, our aim is to develop a risk score for 30-day readmission in ulcerative colitis (UC) patients undergoing colectomy or proctectomy.MethodsThis study used data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) participant user file (2011-2015). Patients with UC undergoing colectomy or proctectomy were identified using ICD-9, 10, and CPT codes. Stepwise multivariate analyses were used to determine risk factors associated with readmission including pre-operative conditions, laboratory results, operative variables, and post-operative complications. For readmission risk score assessment, a weighted logistic regression model was built and validated using ACS NSQIP 2011-2014 and 2015 data, respectively.ResultsA total of 4797 patients were included with 963 (20%) patients readmitted within 30 days. Potentially modifiable risk factors included deep vein thrombosis, pulmonary embolism, renal insufficiency, wound infection, urinary tract infection, sepsis/septic shock, and pre-existing congestive heart failure. Ten percent of patients with a risk score between 0 and 9 were readmitted, 18.5% with a score between 10 and 19, 52.2% with a score between 20 and 29, and 59.6% in patients with a risk score >29.ConclusionsMultiple potentially preventable risk factors are associated with 30-day readmission following colectomy or proctectomy in UC patients. Higher risk scores are associated with increased risk of unplanned readmission.
| S-EPMC6092348 | biostudies-literature
Project description:BackgroundDevelop a clinical and biological predictive model for colectomy risk in children newly diagnosed with ulcerative colitis (UC).MethodsThis was a multicenter inception cohort study of children (ages 4-17 years) newly diagnosed with UC treated with standardized initial regimens of mesalamine or corticosteroids (CS) depending upon initial disease severity. Therapy escalation to immunomodulators or infliximab was based on predetermined criteria. Patients were phenotyped by clinical activity per the Pediatric Ulcerative Colitis Activity Index (PUCAI), disease extent, endoscopic/histologic severity, and laboratory markers. In addition, RNA sequencing defined pretreatment rectal gene expression and high density DNA genotyping by the Affymetrix UK Biobank Axiom Array. Coprimary outcomes were colectomy over 3 years and time to colectomy. Generalized linear models, Cox proportional hazards multivariate regression modeling, and Kaplan-Meier plots were used.ResultsFour hundred twenty-eight patients (mean age 13 years) started initial theapy with mesalamine (n = 136), oral CS (n = 144), or intravenous CS (n = 148). Twenty-five (6%) underwent colectomy at ≤1 year, 33 (9%) at ≤2 years, and 35 (13%) at ≤3 years. Further, 32/35 patients who had colectomy failed infliximab. An initial PUCAI ≥ 65 was highly associated with colectomy (P = 0.0001). A logistic regression model predicting colectomy using the PUCAI, hemoglobin, and erythrocyte sedimentation rate had a receiver operating characteristic area under the curve of 0.78 (95% confidence interval [0.73, 0.84]). Addition of a pretreatment rectal gene expression panel reflecting activation of the innate immune system and response to external stimuli and bacteria to the clinical model improved the receiver operating characteristic area under the curve to 0.87 (95% confidence interval [0.82, 0.91]).ConclusionsA small group of children newly diagnosed with severe UC still require colectomy despite current therapies. Our gene signature observations suggest additional targets for management of those patients not responding to current medical therapies.
| S-EPMC8804885 | biostudies-literature
Project description:BackgroundModels to predict colectomy in ulcerative colitis (UC) are valuable for identification, clinical management, and follow-up of high-risk patients. Our aim was to develop a clinical predictive model based on admission data for one-year colectomy in adults hospitalized for severe UC.MethodsWe performed a retrospective analysis of patients hospitalized at a tertiary academic center for management of severe UC from 1/2013 to 4/2018. Multivariate regression was performed to identify individual predictors of one-year colectomy. Outcome probabilities of colectomy based on the prognostic score were estimated using a bootstrapping technique.ResultsTwo hundred twenty-nine individuals were included in the final analytic cohort. Four independent variables were associated with one-year colectomy which were incorporated into a point scoring system: (+) 1 for single class biologic exposure prior to admission; (+) 2 for multiple classes of biologic exposure; (+) 1 for inpatient salvage therapy with cyclosporine or a TNF-alpha inhibitor; (+) 1 for age <40. The risk probabilities of colectomy within one year in patients assigned scores 1, 2, 3, and 4 were 9.4% (95% CI, 1.7-17.2), 33.7% (95% CI, 23.9-43.5), 58.5% (95% CI, 42.9-74.1), 75.0% (95% CI, 50.5-99.5). An assigned score of zero was a perfect predictor of no colectomy.ConclusionRisk factors most associated with one-year colectomy for severe UC included: prior biologic exposure, need for inpatient salvage therapy, and younger age. We developed a simple scoring system using these variables to identify and stratify patients during their index hospitalization.
| S-EPMC9802419 | biostudies-literature
Project description:BackgroundDue to wide-ranging impacts of Ulcerative Colitis (UC), regulatory authorities emphasize the importance of including validated patient-reported symptom severity measures in clinical trials.AimTo describe the development and validation of the Ulcerative Colitis-Symptom Questionnaire (UC-SQ).MethodsThe UC-SQ was developed in a qualitative study involving a targeted literature review, semi-structured concept elicitation interviews, and combined concept elicitation/cognitive interviews. Measurement properties, including item-level analyses, factor structure, reliability, validity, responsiveness, and clinically meaningful change were evaluated using data from a phase 2b, randomized trial in adults with UC (N = 113).ResultsFourteen symptom concepts were elicited across 22 interviews, with saturation at the fifth interview. Twenty-two items were unmodified as cognitive interview participants interpreted underlying concepts correctly. Instructions were clear and items were relevant, with appropriate response options and recall periods. Reduction to 17 items was completed prior to psychometric testing. Two items (joint pain/constipation) did not contribute to reliability in initial testing and were included as non-scored items. The 15-item UC-SQ showed evidence of internal consistency (α = 0.86) and test-retest reliability (intraclass correlation coefficient = 0.88). The UC-SQ discriminated by disease severity as defined by Mayo and Inflammatory Bowel Disease Questionnaire scores (p < 0.0001). Convergent validity was supported by strong correlations with criterion measures. The UC-SQ was responsive in patients indicating change in other measures. A 10-point decrease from baseline indicated within-patient meaningful improvement.ConclusionsThe UC-SQ is reliable, valid and responsive, with a 10-point improvement estimating within-patient clinically meaningful improvement. The tool is fit-for-purpose as a key endpoint in pivotal UC trials.
| S-EPMC10188579 | biostudies-literature
Project description:If dysplasia is found on biopsies during surveillance colonoscopy for ulcerative colitis (UC), many experts recommend colectomy given the substantial risk of synchronous colon cancer. The objective was to learn if UC patients' perceptions of their colon cancer risk and if their preferences for elective colectomy match with physicians' recommendations if dysplasia was found.A self-administered written survey included 199 patients with UC for at least 8 years (mean age 49 years, 52% female) who were recruited from Dartmouth-Hitchcock (n = 104) and the University of Chicago (n = 95). The main outcome was the proportion of patients who disagree with physicians' recommendations for colectomy because of dysplasia.Almost all respondents recognized that UC raised their chance of getting colon cancer. In all, 74% thought it was "unlikely" or "very unlikely" to get colon cancer within the next 10 years and they quantified this risk to be 23%; 60% of patients would refuse a physician's recommendation for elective colectomy if dysplasia was detected, despite being told that they had a 20% risk of having cancer now. On average, these patients would only agree to colectomy if their risk of colon cancer "right now" were at least 73%.UC patients recognize their increased risk of colon cancer and undergo frequent surveillance to reduce their risk. Nonetheless, few seem prepared to follow standard recommendations for elective colectomy if dysplasia is found. This may reflect the belief that surveillance alone is sufficient to reduce their colon cancer risk or genuine disagreement about when it is worth undergoing colectomy.
| S-EPMC2927807 | biostudies-literature
Project description:BackgroundIncreasing evidence supports immediate colectomy in acute fulminant ulcerative colitis in comparison with ongoing medical management. Prior studies have been limited to inpatient-only administrative data sets or single-institution experiences.ObjectiveThe purpose of this study was to compare outcomes of early versus delayed emergency colectomy in patients admitted with ulcerative colitis flares while controlling for known preoperative risks and acuity.DesignThis is a cohort study of patients undergoing emergent total abdominal colectomies for ulcerative colitis compared by the timing of surgery.SettingAdult patients undergoing an emergent total abdominal colectomy for ulcerative colitis, 2005 to 2015, were identified in the American College of Surgeons National Surgical Quality Improvement Program database.PatientsPatients undergoing total abdominal colectomy with an operative indication of ulcerative colitis admitted on a nonelective basis were selected.Main outcome measureThe primary outcomes measured were 30-day National Surgical Quality Improvement Program-reported mortality and postoperative complications, and early operation within 2 days of admission.ResultsWe identified 573 total abdominal colectomies after propensity score matching. Median time to surgery was 1 hospital day in the early group versus 6 hospital days in the delayed group (p < 0.001). Early operation was associated with a lower mortality rate (4.9% versus 20.3% in matched groups, p < 0.001) and lower complication rate (64.5% versus 72.0%, p = 0.052). Multivariable logistic regression with propensity weighting of mortality on preoperative risk factors demonstrated that early surgery is associated with an 82% decrease in the odds of death compared with delayed surgery (p < 0.001). Regression of morbidity on preoperative risk factors demonstrated that early surgery is associated with a 35% decrease in the odds of a complication with delayed surgery (p = 0.034).LimitationsQuality improvement data were used for clinical research questions.ConclusionsPatients undergoing immediate surgical intervention for acute ulcerative colitis have decreased postoperative complications and mortality rates. Rapid and early transitioning from medical to surgical management may benefit those expected to require surgery on the same admission. See Video Abstract at http://links.lww.com/DCR/A800.
| S-EPMC6456379 | biostudies-literature