Browsing by Subject "Complications"
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Item A Clinical Severity Index for Eosinophilic Esophagitis: Development, Consensus, and Future Directions(Elsevier, 2022) Dellon, Evan S.; Khoury, Paneez; Muir, Amanda B.; Liacouras, Chris A.; Safroneeva, Ekaterina; Atkins, Dan; Collins, Margaret H.; Gonsalves, Nirmala; Falk, Gary W.; Spergel, Jonathan M.; Hirano, Ikuo; Chehade, Mirna; Schoepfer, Alain M.; Menard-Katcher, Calies; Katzka, David A.; Bonis, Peter A.; Bredenoord, Albert J.; Geng, Bob; Jensen, Elizabeth T.; Pesek, Robert D.; Feuerstadt, Paul; Gupta, Sandeep K.; Lucendo, Alfredo J.; Genta, Robert M.; Hiremath, Girish; McGowan, Emily C.; Moawad, Fouad J.; Peterson, Kathryn A.; Rothenberg, Marc E.; Straumann, Alex; Furuta, Glenn T.; Aceves, Seema S.; Pediatrics, School of MedicineBackground & aims: Disease activity and severity of eosinophilic esophagitis (EoE) dictate therapeutic options and management, but the decision-making process for determining severity varies among practitioners. To reduce variability in practice patterns and help clinicians monitor the clinical course of the disease in an office setting, we aimed to create an international consensus severity scoring index for EoE. Methods: A multidisciplinary international group of adult and pediatric EoE researchers and clinicians, as well as non-EoE allergy immunology and gastroenterology experts, formed 3 teams to review the existing literature on histology, endoscopy, and symptoms of EoE in the context of progression and severity. A steering committee convened a 1-day virtual meeting to reach consensus on each team's opinion on salient features of severity across key clinicopathologic domains and distill features that would allow providers to categorize disease severity. Results: Symptom features and complications and inflammatory and fibrostenotic features on both endoscopic and histologic examination were collated into a simplified scoring system-the Index of Severity for Eosinophilic Esophagitis (I-SEE)-that can be completed at routine clinic visits to assess disease severity using a point scale of 0-6 for mild, 7-14 for moderate, and ≥15 for severe EoE. Conclusions: A multidisciplinary team of experts iteratively created a clinically usable EoE severity scoring system denominated "I-SEE" to guide practitioners in EoE management by standardizing disease components reflecting disease severity beyond eosinophil counts. I-SEE should be validated and refined using data from future clinical trials and routine clinical practice to increase its utilization and functionality.Item A Sodium Oxychlorosene-Based Infection Prevention Protocol Safely Decreases Postoperative Wound Infections in Adult Spinal Deformity Surgery(Springer Nature, 2024-03-13) Alentado, Vincent J.; Kazi, Fezaan A.; Potts, Caroline A.; Zaazoue, Mohamed A.; Pott, Eric A.; Khairi, Saad A.; Neurological Surgery, School of MedicineIntroduction: This study sought to determine the efficacy of a complex multi-institutional sodium oxychlorosene-based infection protocol for decreasing the rate of surgical site infection after instrumented spinal surgery for adult spinal deformity (ASD). Infection prevention protocols have not been previously studied in ASD patients. Methods: A retrospective analysis was performed of patients who underwent posterior instrumented spinal fusion of the thoracic or lumbar spine for deformity correction between January 1, 2011, and May 31, 2019. The efficacy of a multi-modal infection prevention protocol was examined. The infection prevention bundle consisted of methicillin-resistant Staphylococcus aureus testing, chlorhexidine gluconate bathing preoperatively, sodium oxychlorosene rinse, vancomycin powder placement, and surgical drain placement at the time of surgery. Results: About 254 patients fit the inclusion criteria. Among these patients, nine (3.5%) experienced post-surgical deep-wound infection. Demographics and surgical characteristics amongst infected and non-infected cohorts were similar, although diabetes trended towards being more prevalent in patients who developed a postoperative wound infection (p=0.07). Among 222 patients (87.4%) who achieved a minimum of two years of follow-ups, 184 patients (82.9%) experienced successful fusion, comparing favorably with pseudarthrosis rates in the ASD literature. Rates of pseudarthrosis and proximal junction kyphosis were similar amongst infected and non-infected patients. Conclusion: An intraoperative comprehensive sodium oxychlorosene-based infection prevention protocol helped to provide a low rate of infection after major deformity correction without negatively impacting other postoperative procedure-related metrics.Item Assessment and management of hypertension in patients on dialysis(American Society of Nephrology, 2014-08) Agarwal, Rajiv; Flynn, Joseph; Pogue, Velvie; Rahman, Mahboob; Reisin, Efrain; Weir, Matthew R.; Department of Medicine, IU School of MedicineHypertension is common, difficult to diagnose, and poorly controlled among patients with ESRD. However, controversy surrounds the diagnosis and treatment of hypertension. Here, we describe the diagnosis, epidemiology, and management of hypertension in dialysis patients, and examine the data sparking debate over appropriate methods for diagnosing and treating hypertension. Furthermore, we consider the issues uniquely related to hypertension in pediatric dialysis patients. Future clinical trials designed to clarify the controversial results discussed here should lead to the implementation of diagnostic and therapeutic techniques that improve long-term cardiovascular outcomes in patients with ESRD.Item Assessment of morbidity and mortality after liver transplantation for primary sclerosing cholangitis(AME, 2024) Ekser, Burcin; Mihaylov, Plamen; Mangus, Richard S.; Surgery, School of MedicineItem Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C(Wiley, 2013) Molleston, Jean P.; Mellman, William; Narkewicz, Michael R.; Balistreri, William F.; Gonzalez-Peralta, Regino P.; Jonas, Maureen M.; Lobritto, Steven J.; Mohan, Parvathi; Murray, Karen F.; Njoku, Dolores; Rosenthal, Philip; Barton, Bruce A.; Talor, Monica V.; Cheng, Irene; Schwarz, Kathleen B.; Haber, Barbara A.; Peds-C Clinical Research Net; Pediatrics, School of MedicineObjectives: Autoantibodies were studied in a well-characterized cohort of children with chronic hepatitis C during treatment with pegylated interferon and ribavirin to assess the relation with treatment and development of autoimmune disease. Methods: : A total of 114 children (5-17 years), screened for the presence of high-titer autoantibodies, were randomized to pegylated interferon with or without ribavirin. Anti-nuclear, anti-liver-kidney-microsomal, anti-thyroglobulin, anti-thyroid peroxidase, insulin, anti-glutamic acid decarboxylase (GAD) antibodies were measured after trial completion using frozen sera. Results: At baseline, 19% had autoantibodies: anti-nuclear antibodies (8%), anti-liver-kidney-microsomal antibodies (4%), and glutamic acid decarboxylase antibodies (4%). At 24 and 72 weeks (24 weeks after treatment completion), 23% and 26% had autoantibodies (P=0.50, 0.48 compared with baseline). One child developed diabetes and 2 hypothyroidism during treatment; none developed autoimmune hepatitis. At 24 weeks, the incidence of flu-like symptoms, gastrointestinal symptoms, and headaches was 42%, 8% and 19% in those with autoantibodies versus 52%, 17%, and 26% in those without (P=0.18, 0.36, and 0.20, respectively). In children with negative hepatitis C virus polymerase chain reaction at 24 weeks, there was no difference in the rate of early virologic response/sustained virologic response, respectively, in those with autoantibodies 76%/69% vs 58%/65% in those without (P=0.48). Conclusions: Despite screening, we found autoantibodies commonly at baseline, during treatment for chronic hepatitis C and after. The presence of antibodies did not correlate with viral response, adverse effects, or autoimmune hepatitis. Neither screening nor archived samples assayed for thyroid and diabetes-related antibodies identified the 3 subjects who developed overt autoimmune disease, diabetes (1), and hypothyroidism (2).Item Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial(Elsevier, 2019-10) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Wallace, Michael B.; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of MedicineBackground & aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon.Item Collaboration Is Key for Successful Treatment of Youth-Onset Type 2 Diabetes(Elsevier, 2017-04) Folsom, Lisal J.; Hannon, Tamara S.; Pediatrics, School of MedicineType 2 diabetes (T2D) is increasing in U.S. adolescents, particularly those of ethnic and racial minority groups. Risk factors for youth-onset T2D include obesity, family history of T2D, poor diet, lack of exercise, and poverty. The onset of diabetes-related complications is accelerated in adolescents with T2D compared to adults, and knowledge regarding the optimal way to prevent and slow complications is lacking. Existing treatment options are limited, and research into novel pharmacologic treatments is hindered by lack of sufficient patient population for clinical trials. Health care providers and investigators should collaborate both with each other, and with patients and their communities to build networks that will allow comprehensive evaluation of this disease in order to offer optimal, comprehensive care for these adolescents.Item Comparative Responsiveness of Pain Measures in Cancer Patients(Elsevier, 2012-08) Kroenke, Kurt; Theobald, Dale; Wu, Jingwei; Tu, Wanzhu; Krebs, Erin E.; Department of Medicine, IU School of MedicineBrief measures to assess and monitor pain in cancer patients are available, but few head-to-head psychometric comparisons of different measures have been reported. Baseline and 3-month data were analyzed from 274 patients enrolled in the Indiana Cancer Pain and Depression (INCPAD) trial. Participants completed the Brief Pain Inventory (BPI), the PEG (a 3-item abbreviated version of the BPI), the short form (SF)-36 pain scale, and a pain global rating of change measure. The global rating was used as the criterion for standardized response mean and receiver operating characteristic curve analyses. To assess responsiveness to the trial intervention, we evaluated standardized effect size statistics stratified by trial arm. All measures were responsive to global improvement, discriminated between participants with and without improvement, and detected a significant intervention treatment effect. Short and longer measures were similarly responsive. Also, composite measures that combined pain severity and interference into a single score (BPI total, PEG, SF-36 pain) performed comparably to separate measures of each domain (BPI severity and BPI interference).Item Comparing general and regional anesthesia in patients undergoing primary total hip arthroplasty: analysis of national health insurance data in Korea(Frontiers Media, 2025-03-17) Lee, Seungyoung; Ahn, Eunjin; Kim, Min Kyoung; White, Fletcher A.; Chung, Euiheon; Chung, YongHun; Anesthesia, School of MedicineObjectives: To compare the effects of general and regional anesthesia on clinical outcomes following primary total hip arthroplasty (THA). Methods: This retrospective study using data from the Korean National Health Insurance Research Database included 1,522 patients who underwent THA under general anesthesia (n = 640) or regional anesthesia (n = 882) between 2002 and 2015. We compared the mortality and complication rates within 30 days after surgery. Results: Prosthesis failure (1.56% vs. 0.45%, p = 0.025), admission to the intensive care unit (9.53 vs. 5.44%, p = 0.0023), and total cost (₩7,332,515 vs. ₩6,833,295, p < 0.0001) were higher in the general anesthesia group than in the regional anesthesia group. No significant differences were observed in mortality (0.94% vs. 0.57%, p = 0.54), transfusion rate (81.1% vs. 80.9%, p = 0.94), length of hospital stay (45 vs. 45 days, p = 0.23), or other complications between the groups. Similar results were observed in propensity-score matched analysis (n = 640 patients per group). Conclusion: Our study showed that both anesthesia types resulted in comparable mortality and complication rates in patients who underwent THA, but the costs differed.Item Comparison of isoflurane and α-chloralose in an anesthetized swine model of acute pulmonary embolism producing right ventricular dysfunction(American Association for Laboratory Animal Science, 2015-02) Beam, Daren M.; Neto-Neves, Evandro M.; Stubblefield, William B.; Alves, Nathan J.; Tune, Johnathan D.; Kline, Jeffrey A.; Department of Emergency Medicine, IU School of MedicinePulmonary embolism (PE) is a leading cause of sudden cardiac death, and a model is needed for testing potential treatments. In developing a model, we compared the hemodynamic effects of isoflurane and α-chloralose in an acute swine model of PE because the choice of anesthesia will likely affect the cardiovascular responses of an animal to PE. At baseline, swine that received α-chloralose (n = 6) had a lower heart rate and cardiac output and higher SpO2, end-tidal CO2, and mean arterial pressure than did those given isoflurane (n = 9). After PE induction, swine given α-chloralose compared with isoflurane exhibited a lower heart rate (63 ± 10 compared with 116 ± 15 bpm) and peripheral arterial pressure (52 ± 12 compared with 61 ± 12 mm Hg); higher SpO2 (98% ± 3% compared with 95% ± 1%), end-tidal CO2 (35 ± 4 compared with 32 ± 5), and systolic blood pressure (121 ± 8 compared with 104 ± 20 mm Hg); and equivalent right ventricular:left ventricular ratios (1.32 ± 0.50 compared with 1.23 ± 0.19) and troponin I mean values (0.09 ± 0.07 ng/mL compared with 0.09 ± 0.06 ng/mL). Isoflurane was associated with widely variable fibrinogen and activated partial thromboplastin time. Intraexperiment mortality was 0 of 6 animals for α-chloralose and 2 of 9 swine for isoflurane. All swine anesthetized with α-chloralose survived with sustained pulmonary hypertension, RV-dilation-associated cardiac injury without the confounding vasodilatory or coagulatory effects of isoflurane. These data demonstrate the physiologic advantages of α-chloralose over isoflurane for anesthesia in a swine model of severe submassive PE.