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1.
Clin Gastroenterol Hepatol ; 21(13): 3405-3414.e4, 2023 12.
Article in English | MEDLINE | ID: mdl-37482172

ABSTRACT

BACKGROUND & AIMS: Cannabis (delta-9-tetrahydrocannabinol), a nonselective cannabinoid-receptor agonist, relieves nausea and pain. Cannabidiol (CBD), a cannabinoid receptor 2 inverse agonist with central effects, also reduces gut sensation and inflammation. We compared the effects of 4 weeks of treatment with pharmaceutical CBD vs placebo in patients with idiopathic or diabetic (diabetes mellitus) gastroparesis. METHODS: We performed a randomized, double-blinded, placebo-controlled study of CBD twice daily (Epidiolex escalated to 20 mg/kg/d; Jazz Pharmaceuticals, Dublin, Ireland) in patients with nonsurgical gastroparesis with delayed gastric emptying of solids (GES). Symptoms were assessed by the Gastroparesis Cardinal Symptom Index Daily Diary. After 4 weeks of treatment, we measured GES, gastric volumes, and Ensure (Abbott Laboratories, Abbott Park, IL) satiation test (1 kcal/mL, 30 mL/min) to assess volume to comfortable fullness and maximum tolerance. Patients underwent specific FAAH and CNR1 genotyping. Statistical analysis compared 2 treatments using analysis of variance including baseline measurements and body mass index as covariates. RESULTS: Among 44 patients (32 idiopathic, 6 diabetes mellitus type 1, and 6 diabetes mellitus type 2), 5 patients did not tolerate full-dose escalation; 3 withdrew before completing 4 weeks of treatment (2 placebo, 1 CBD); 95% completed 4 weeks of treatment and diaries. Compared with placebo, CBD reduced the total Gastroparesis Cardinal Symptom Index score (P = .008), inability to finish a normal-sized meal (P = .029), number of vomiting episodes/24 hours (P = .006), and overall symptom severity (P = .034). Patients treated with CBD had a higher volume to comfortable fullness and maximum tolerance and slower GES. FAAH rs34420 genotype significantly impacted nutrient drink ingestion. The most common adverse events reported were diarrhea (14 patients), fatigue (8 patients), headache (8 patients), and nausea (7 patients). CONCLUSIONS: CBD provides symptom relief in patients with gastroparesis and improves the tolerance of liquid nutrient intake, despite slowing of GES. CLINICALTRIALS: gov NCT #03941288.


Subject(s)
Cannabidiol , Diabetes Mellitus, Type 1 , Gastroparesis , Humans , Gastroparesis/drug therapy , Cannabidiol/adverse effects , Drug Inverse Agonism , Nausea/chemically induced , Gastric Emptying
2.
BMC Cancer ; 22(1): 221, 2022 Feb 28.
Article in English | MEDLINE | ID: mdl-35227234

ABSTRACT

BACKGROUND: Hepatocellular carcinoma (HCC) has high incidence and mortality worldwide. Local ablation using radiofrequency ablation (RFA) or microwave ablation (MWA) is potentially curative for early-stage HCC with outcomes comparable to surgical resection. We explored the influence of demographic, clinical, and laboratory factors on outcomes of HCC patients receiving ablation. METHODS: This retrospective cohort study included 221 HCC patients receiving local ablation at Mayo Clinic between January 2000 and October 2018, comprising 140 RFA and 81 MWA. Prognostic factors determining overall survival (OS) and disease-free survival (DFS) were identified using multivariate analysis. RESULTS: There was no clinically significant difference in OS or DFS between RFA and MWA. In multivariate analysis of OS, pre-ablation lymphocyte-monocyte ratio [Hazard ratio (HR) 0.7, 95% confidence interval (CI) 0.58-0.84, P = 0.0001], MELD score [HR 1.12, 95%CI 1.068-1.17, P <  0.0001], tumor number [HR 1.23, 95%CI 1.041-1.46, P = 0.015] and tumor size [HR 1.18, 95%CI 1.015-1.37, P = 0.031] were clinically-significant prognostic factors. Among HCC patients with chronic hepatitis C (HCV) infection, positive HCV PCR at HCC diagnosis was associated with 1.4-fold higher hazard of death, with 5-year survival of 32.8% vs 53.6% in HCV PCR-negative patients. Regarding DFS, pre-ablation lymphocyte-monocyte ratio [HR 0.77, 95%CI 0.66-0.9, P = 0.001], MELD score [HR 1.06, 95%CI 1.022-1.11, P = 0.002], Log2 AFP [HR 1.11, 95%CI 1.033-1.2, P = 0.005], tumor number [HR 1.29, 95%CI 1.078-1.53, P = 0.005] and tumor size [HR 1.25, 95%CI 1.043-1.51 P = 0.016] were independently prognostic. CONCLUSIONS: Pre-ablation systemic inflammation represented by lymphocyte-monocyte ratio is significantly associated with OS and DFS in HCC patients treated with local ablation. HCV viremia is associated with poor OS. Tumor biology represented by tumor number and size are strongly prognostic for OS and DFS while AFP is significantly associated with DFS only.


Subject(s)
Carcinoma, Hepatocellular/blood , Hepatitis C, Chronic/blood , Inflammation Mediators/blood , Liver Neoplasms/blood , Radiofrequency Ablation , Aged , Biomarkers, Tumor/blood , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/virology , Female , Hepacivirus , Hepatitis C, Chronic/complications , Humans , Liver Neoplasms/mortality , Liver Neoplasms/virology , Male , Middle Aged , Prognosis , Proportional Hazards Models , Retrospective Studies , Survival Rate , Treatment Outcome
3.
J Clin Gastroenterol ; 2022 Dec 30.
Article in English | MEDLINE | ID: mdl-36728679

ABSTRACT

BACKGROUND: Obesity is on the rise within the inflammatory bowel disease population. The impact obesity has on the natural history of Crohn's disease (CD) is not well-understood. We aimed to describe the prevalence of obesity in a population-based cohort of newly diagnosed patients with CD, and the impact obesity had on disease phenotype and outcomes of corticosteroid use, hospitalization, intestinal resection, and development of fistulizing or penetrating disease. MATERIALS AND METHODS: A chart review was performed on Olmsted County, Minnesota residents diagnosed with CD between 1970 and 2010. Data were collected on demographics, body mass index, CD location and behavior, CD-related hospitalizations, corticosteroid use, and intestinal resection. The proportion of individuals considered obese at the time of CD diagnosis was evaluated over time, and CD-associated complications were assessed with Kaplan-Meier survival analysis. RESULTS: We identified 334 individuals diagnosed with CD between 1970 and 2010, of whom 156 (46.7%) were either overweight (27.8%) or obese (18.9%) at the time of diagnosis. The proportion of patients considered obese at the time of their diagnosis of CD increased 2-3 fold over the course of the study period. However, obesity did not have a significant impact on the future risk of corticosteroid use, hospitalization, intestinal resection, or development of penetrating and stricturing complications. CONCLUSIONS: Obesity is on the rise in patients with CD, although in this cohort, there did not appear to be any negative association with future CD-related outcomes. Further prospective studies, ideally including obesity measures such as visceral adipose tissue assessment, are warranted to understand the implications of the rising prevalence of obesity on CD outcomes.

4.
J Pediatr Gastroenterol Nutr ; 72(6): 859-865, 2021 06 01.
Article in English | MEDLINE | ID: mdl-33976086

ABSTRACT

OBJECTIVES: Excessive fecal bile acids in adults have been associated with diarrhea-predominant irritable bowel syndrome (IBS-D), but their role in pediatric IBS-D is unknown. Serum markers including 7α-hydroxy-4-cholesten-3-one (C4) and fibroblast growth factor-19 (FGF-19) were validated in adults to detect bile acid diarrhea (BAD) compared to 48-hour fecal bile acid collection (48FBA). Our aims were to assess fasting serum C4 and FGF-19 and 48FBA in a pediatric population, to compare measurements in IBS-D patients and healthy controls (HC), and to determine the prevalence of BAD among children with IBS-D. METHODS: Using a cross-sectional design, 26 patients with IBS-D and 56 HC were recruited in two pediatric tertiary care centers. Fasting serum C4 and FGF-19 and 48FBA were obtained. Participants completed a 7-day bowel diary coinciding with stool collection. Associations were analyzed using Spearman correlations. RESULTS: Mean age was 14.7 ±â€Š2.5 years (42.3% female) in IBS-D and 12.6 ±â€Š2.4 years (39.3% female) in HC. There was a significant correlation of C4 with 48FBA (r = 0.48, P < 0.05) and an inverse association with FGF-19 (r = -0.43, P < 0.05). No significant differences were noted in C4 (P = 0.32), FGF-19 (P = 0.1), or 48FBA (P = 0.5) between IBS-D and HC groups; however, 20% of IBS-D patients had elevated C4 and 28% had low FGF-19 values.Fecal primary BA was significantly correlated with stool frequency (r = 0.45, P < 0.002). CONCLUSIONS: Correlations of C4 with 48FBA and FGF-19 are confirmed in a pediatric population. Twenty percent of pediatric patients with IBS-D had abnormal fasting serum C4. This serum test could be applied to identify BAD in pediatric IBS-D.


Subject(s)
Irritable Bowel Syndrome , Adolescent , Adult , Bile Acids and Salts , Biomarkers , Child , Cross-Sectional Studies , Diarrhea/etiology , Feces , Female , Humans , Male
5.
Dig Dis Sci ; 66(9): 3096-3104, 2021 09.
Article in English | MEDLINE | ID: mdl-32995996

ABSTRACT

BACKGROUND: Identification of clinical predictors of response to first-line therapies for EoE is needed to guide initial medical management. STUDY DESIGN: A retrospective analysis of patients diagnosed with EoE from 2011 to 2018 was conducted. Clinical and diagnostic variables including demographics, endoscopic, and esophagram findings were compared between PPI responders and PPI nonresponders. All patients underwent a standard 8-week twice-daily PPI trial, with PPI responsiveness defined as < 15 eos/hpf on repeat EGD. Univariate and multivariable analyses were conducted to identify risk factors for nonresponse, and ROC curves were created to identify cutoff values. RESULTS: A total of 223 EoE patients (135 male, median age 39 (29-51)) were identified, with PPI nonresponse (PPI-NR) in 71% of patients. PPI-NR was seen in all 10 patients with failure of scope passage, with an OR of 9.06 by univariate analysis (P = 0.1485). In a multivariable model, age per 10 years (OR 0.71; P = 0.007), BMI per 1 kg/m2 (OR 0.94; P = 0.03), and peripheral eosinophil count per 100 per mm3 (OR 1.37; P = 0.003) were independent risk factors. Dichotomization to maximize sensitivity and specificity identified age ≤ 36 years old, BMI ≤ 25.2 kg/m2, and peripheral eos > 460 per mm3 as predictive thresholds for PPI-NR. The probability of PPI-NR was 72.4-84.5% with 1 risk factor, 87.9-93.8% with 2 risk factors, and 97.2% with all 3 risk factors. CONCLUSIONS: Young age, reduced BMI, elevated peripheral eosinophil count, and likely inability to pass an endoscope predict lack of response to PPIs in patients with EoE.


Subject(s)
Drug Resistance , Endoscopy/methods , Eosinophilic Esophagitis , Eosinophils , Esophagus , Proton Pump Inhibitors , Adult , Biopsy/methods , Body Mass Index , Drug Monitoring/methods , Eosinophilic Esophagitis/blood , Eosinophilic Esophagitis/diagnosis , Eosinophilic Esophagitis/drug therapy , Eosinophilic Esophagitis/epidemiology , Esophagus/diagnostic imaging , Esophagus/pathology , Female , Humans , Leukocyte Count/methods , Male , Predictive Value of Tests , Prognosis , Proton Pump Inhibitors/administration & dosage , Proton Pump Inhibitors/adverse effects , Retrospective Studies , Sensitivity and Specificity , United States/epidemiology
6.
AJR Am J Roentgenol ; 206(3): 655-9, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26901024

ABSTRACT

OBJECTIVE: The purpose of this study is to assess the complication rate and diagnostic accuracy of percutaneous image-guided core needle biopsy (CNB) of the spleen at a single center over the course of 12 years. MATERIALS AND METHODS: A retrospective review of an institutionally maintained biopsy database was used to identify CNBs of the spleen performed between October 2002 and January 2015. Clinical notes were reviewed from the date of biopsy to 3 months after biopsy to ascertain whether any immediate or delayed complications had occurred. Minor complications included pain requiring analgesia and incidental asymptomatic bleeding. Major complications were those scored at or above grade 3 according to the National Institutes of Health's Common Terminology Criteria for Adverse Events, version 4.0. The pathology reports issued for each specimen were evaluated and compared with results obtained from splenectomy, biopsy performed at another anatomic site, or longitudinal clinical or imaging follow-up. Sensitivity, specificity, and accuracy were calculated. RESULTS: A total of 97 CNBs of the spleen were performed, 23 of which were CT guided and 74 of which were ultrasound guided. There were seven (7.2%) minor complications and a single (1.0%) major complication; the overall complication rate was 8.2% (n = 8). The diagnostic yield-defined as adequate tissue to establish a diagnosis-of CNB was 93.8%, the sensitivity was 90.7%, the specificity was 100%, and the accuracy was 94.5%. CONCLUSION: Percutaneous image-guided CNB of the spleen is safe and effective in achieving a tissue diagnosis.


Subject(s)
Biopsy, Large-Core Needle/adverse effects , Image-Guided Biopsy/adverse effects , Spleen/pathology , Splenic Diseases/pathology , Aged , Female , Hematoma/etiology , Hemothorax/etiology , Humans , Male , Pain, Postoperative/etiology , Reproducibility of Results , Retrospective Studies , Sensitivity and Specificity , Tomography, X-Ray Computed , Treatment Outcome , Ultrasonography, Interventional
7.
Crohns Colitis 360 ; 6(1): otae010, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38528940

ABSTRACT

Introduction: The aim of this case-control study was to determine if exposure to tumor necrosis factor alpha inhibitors (TNFIs) or immunomodulators (thiopurines or methotrexate) was associated with development of primary gastrointestinal lymphoma (PGIL) in patients with chronic inflammatory conditions. Methods: Patients with PGIL and controls evaluated at a tertiary care center over 20 years were matched 1:3 using a medical record informatics search engine based on their chronic inflammatory condition (Crohn's disease [CD], ulcerative colitis [UC], rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis) and duration of follow-up. Patients who started on TNFI within 3 months of PGIL diagnosis were excluded. We extracted demographics, medical history, and medications used. Univariate models using conditional logistic regression were used due to the small number of matched pairs. Results: Twenty PGIL cases matched with 60 controls were followed for a mean 9.9 ±â€…6.9 and 9.7 ±â€…8.6 years, respectively. Mean age at time of PGIL diagnosis was 47.5 ±â€…22.0 (standard deviation) years and the majority (75%) were males. The most common inflammatory diagnosis was inflammatory bowel disease (80% of cases; 45% with UC and 35% with CD). Development of PGIL was not associated with TNFI (odds ratio [OR] = 2.6; 95% confidence interval [CI] 0.69-11.01; P = .18), but with use of TNFI in combination with thiopurines (OR = 8.93; 95% CI 1.43-80.25; P = .014). Risk of PGIL increased with every additional TNFI (2.277 (1.002-5.713); P = .0494). All cases exposed to multiple TNFI were also exposed to thiopurines. Use of thiopurines (alone or in combination) was the greatest risk factor (OR = 6.32; 95% CI 1.55-37.05; P = 0.006) to develop PGIL. Conclusions: TNFI therapy was not associated with increased risk for PGIL unless used in combination with thiopurines and with every switch to a different TNFI.

8.
Ann Surg Oncol ; 19(10): 3230-5, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22820939

ABSTRACT

PURPOSE: The purposes of this study are (1) to determine our institution's rate of venous thromboembolic events (VTE) and hematomas following breast surgery, and (2) to compare our breast surgery VTE rate with both our general surgery population and the National surgical quality improvement program (NSQIP) dataset. METHODS: Prospectively collected NSQIP data from April 2006 to June 2010 were analyzed. Our institution's VTE rates, pharmacologic prophylaxis (PCP) utilization, and hematomas were reviewed for patients undergoing breast surgery. The VTE rate was compared with NSQIP patient populations. RESULTS: Among 4,579 breast operations at our institution over this time period, 988 (21.6 %) were analyzed through NSQIP. The VTE rate following breast operations was 4/988 (0.4 %): 0/236 for those with benign disease and 4/752 (0.5 %) for those with breast cancer (p = 0.58). PCP was received by 147/752 (19.5 %) cancer patients. In cancer patients, the hematoma rate requiring reoperation was 3/147 (2.0 %) in those receiving PCP and 12/605 (2.0 %) in those not receiving PCP (p = 1.0). Breast surgery patients had a similar VTE rate compared with the institutional general surgery population (0.7 %, p = 0.254) and versus national general surgery patients from NSQIP (0.7 %, p = 0.29). Our institution's VTE incidence for patients with breast cancer undergoing mastectomy was significantly higher than "like" NSQIP centers. CONCLUSIONS: Our breast surgery VTE rate was similar to our general surgery population. Our mastectomy population had a higher VTE incidence compared with other NSQIP sites. Patients undergoing mastectomy, especially if combined with axillary lymph node dissection or reconstruction, should be considered for routine PCP.


Subject(s)
Breast Neoplasms/surgery , Hematoma/etiology , Mammaplasty , Mastectomy/adverse effects , Postoperative Complications , Quality Improvement , Venous Thromboembolism/etiology , Adult , Anticoagulants/therapeutic use , Breast Neoplasms/complications , Breast Neoplasms/pathology , Female , Follow-Up Studies , Hematoma/drug therapy , Humans , Middle Aged , Prognosis , Prospective Studies , Risk Factors , Time Factors , Venous Thromboembolism/drug therapy
9.
Ann Rheum Dis ; 70(12): 2082-8, 2011 Dec.
Article in English | MEDLINE | ID: mdl-22021865

ABSTRACT

OBJECTIVE: To study 90-day complications following total hip arthroplasty (THA) or total knee arthroplasty (TKA). METHOD: In a population-based cohort of all Olmsted County residents who underwent a THA or TKA (1994-2008), we assessed 90-day occurrence and predictors of cardiac complications (myocardial infarction, cardiac arrhythmia or congestive heart failure), thromboembolic complications (deep venous thrombosis or pulmonary embolism) and mortality. RESULTS: 90-day complication rates after THA and TKA were: cardiac, 6.9% and 6.7%; thromboembolic, 4.0% and 4.9%; and mortality, 0.7% and 0.4%, respectively. In multivariable-adjusted logistic regression analyses, ASA class III-IV (OR 6.1, 95% CI:1.6-22.8) and higher Deyo-Charlson comorbidity score (OR 1.2, 95% CI:1.0-1.4) were significantly associated with odds of 90-day cardiac event post-THA in patients with no known previous cardiac event. In those with known previous cardiac disease, ASA class III-IV (OR 4.4, 95% CI:2.0-9.9), male gender (OR 0.5, 95% CI:0.3-0.9) and history of thromboembolic disease (OR 3.2; 95% CI:1.4-7.0) were significantly associated with odds of cardiac complication 90 days post-THA. No significant predictors of thromboembolism were found in THA patients. In TKA patients with no previous cardiac history, age >65 years (OR 4.1, 95% CI:1.2-14.0) and in TKA patients with known cardiac disease, ASA class III-IV (OR 3.2, 95% CI:1.8-5.7) was significantly associated with odds of 90-day cardiac events. In TKA patients with no previous thromboembolic disease, male gender (OR 0.5, 95% CI:0.2-0.9) and higher Charlson index (OR 1.2, 95% CI:1.1-1.3) and in patients with known thromboembolic disease, higher Charlson index score (OR 1.2, 95% CI:1.1-1.4) was associated with odds of 90-day thromboembolic events. CONCLUSION: Older age, higher comorbidity, higher ASA class and previous history of cardiac/thromboembolic disease were associated with an increased risk.


Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Postoperative Complications , Thromboembolism/epidemiology , Age Factors , Aged , Arthroplasty, Replacement, Hip/mortality , Arthroplasty, Replacement, Knee/mortality , Cardiovascular Diseases/epidemiology , Comorbidity , Epidemiologic Methods , Female , Humans , Male , Middle Aged , Minnesota/epidemiology , Sex Factors
10.
J Cancer Epidemiol ; 2021: 2670502, 2021.
Article in English | MEDLINE | ID: mdl-34899912

ABSTRACT

BACKGROUND: Early-onset gastric cancer (EOGC, age ≤ 60 years at diagnosis) now comprises >30% of new gastric cancers in the United States. It is hypothesized that chronic acid suppression with proton-pump inhibitors (PPIs) may promote tumorigenesis, while other medications including statins, nonsteroidal anti-inflammatory drugs (NSAIDs), metformin, and cyclooxygenase-2 (COX-2) inhibitors have been proposed as protective. We aimed to assess for an association between use of the aforementioned commonly prescribed medications and EOGC development. METHODS: We used a population-based medical record linkage system, to identify cases of EOGC in Olmsted County, Minnesota, between January 1, 1995, and December 31, 2020. Patients were matched 1 : 1 with controls based on age at diagnosis, sex, smoking status, and body mass index (BMI). Conditional logistic regression was used to examine associations with the odds of EOGC development. RESULTS: Ninety-six cases of EOGC were identified during the study period. On both univariate and multivariate regression analysis, there was no significant association between use of PPIs, statins, NSAIDs, or metformin and EOGC development. In a final multivariable model, there was a significant reduction in odds of EOGC with COX-2 inhibitor use for six months or more prior to cancer diagnosis (OR = 0.39, 95% CI 0.16-0.94). CONCLUSION: In this retrospective, population-based study of individuals in Olmsted County, MN, we found significantly reduced odds of EOGC development associated with COX-2 inhibitor use for six months or more prior to diagnosis, but no association between EOGC development and use of PPIs and other commonly prescribed medications.

11.
Arthroscopy ; 26(9 Suppl): S142-7, 2010 Sep.
Article in English | MEDLINE | ID: mdl-20691562

ABSTRACT

PURPOSE: The purposes of this study was to better understand the utilization of anterior acromioplasty over time, in the absence of rotator cuff repair; to examine the relation to patient characteristics (age, sex) and types of rotator cuff pathology (inflammation or fibrosis, partial-thickness tearing, full-thickness tearing undergoing debridement); and to assess the utilization of arthroscopy in this procedure. METHODS: Using the resources of the Rochester Epidemiology Project, cataloging medical records of residents in Olmsted County, Minnesota, we identified 246 patients who underwent anterior acromioplasty between 1980 and 2005. It has previously been shown that rarely does a resident of Olmsted County undergo an orthopaedic procedure at a facility outside the county. RESULTS: The incidence of anterior acromioplasty increased over time (P < .001), with crude rates of 3.3 per 100,000 persons in 1980 to 1985 and 19.0 per 100,000 persons in 2000 to 2005. Sex, age, and types of rotator cuff pathology did not significantly change over the 26-year period. There was a dramatic shift from use of the open approach to the arthroscopic approach over this time period (P < .001) and a decrease in the concomitant performance of distal clavicle resection (P < .001). CONCLUSIONS: The frequency of anterior acromioplasty has dramatically increased over time. Increasing knowledge about this syndrome, including better imaging, has facilitated patient treatment for a stable spectrum of rotator cuff pathology (inflammation or fibrosis, partial-thickness tearing, full-thickness tearing undergoing debridement), as has the application of endoscopic surgery. LEVEL OF EVIDENCE: Level III, epidemiologic study.


Subject(s)
Acromion/surgery , Arthroscopy/trends , Rotator Cuff , Shoulder Impingement Syndrome/surgery , Tendinopathy/surgery , Adolescent , Adult , Aged , Aged, 80 and over , Arthroscopy/methods , Arthroscopy/statistics & numerical data , Debridement , Female , Fibrosis , Humans , Incidence , Male , Middle Aged , Minnesota/epidemiology , Orthopedic Procedures/statistics & numerical data , Rotator Cuff/pathology , Rotator Cuff/surgery , Rotator Cuff Injuries , Shoulder Impingement Syndrome/epidemiology , Tendinopathy/complications , Tendinopathy/epidemiology , Wounds and Injuries/epidemiology , Young Adult
12.
Crohns Colitis 360 ; 2(4): otaa083, 2020 Oct.
Article in English | MEDLINE | ID: mdl-34142084

ABSTRACT

BACKGROUND: We sought to estimate the incidence of home parenteral nutrition (HPN) use in a population-based cohort of patients with Crohn disease (CD), and to assess clinical outcomes and complications associated with HPN. METHODS: We used the Rochester Epidemiology Project (REP) to identify residents of Olmsted County, who were diagnosed with CD between 1970 and 2011, and required HPN. RESULTS: Fourteen out of 429 patients (3.3%) with CD received HPN (86% female). Eleven patients (79%) had moderate-severe CD and 12 patients (86%) had fistulizing disease. Thirteen patients (93%) underwent surgery, primarily due to obstruction. Among CD incidence cases, the cumulative incidence of HPN from the date of CD diagnosis was 0% at 1 year, 0.5% at 5 years, 0.8% at 10 years, and 2.4% at 20 years. Indications for HPN included short bowel syndrome in 64%, malnutrition in 29%, and bowel rest in 21%. The median duration of HPN was 2.5 years. There was an average weight gain of 1.2 kg at 6 months, an average weight loss of 1.4 kg at 1 year, and a further weight loss of 2.2 kg at 2 years from the start of HPN. Patients were hospitalized a mean of 5 times after the start of HPN, mainly due to catheter-related bloodstream infections and thrombosis. CONCLUSIONS: Less than 4% of patients with CD need HPN. Most have moderate to severe disease with short bowel syndrome or malnutrition. Possible reasons for the patients' weight loss could be noncompliance, and increased metabolic needs because of active disease.

13.
Semin Radiat Oncol ; 29(4): 311-317, 2019 10.
Article in English | MEDLINE | ID: mdl-31472731

ABSTRACT

Randomized controlled trials have been considered the gold standard in informing clinical decision-making while observational studies have generally been utilized to generate hypotheses for future studies. The rising cost of randomized studies along with increased difficulty in accrual has led the clinical community to consider utilizing observational studies to inform clinical decisions. Various statistical methods exist to analyze observational data. Researchers must consider each method carefully, paying specific attention to its ability to answer the hypotheses, while ensuring the underlying assumptions are met. While each has its own strengths and weaknesses, research has shown that each method may yield similar estimates of treatment effect when conducted appropriately. We describe several commonly used analytical methods including their: strengths, weaknesses, and common missteps in order to inform and serve as a reference to the broader oncology community.


Subject(s)
Clinical Decision-Making/methods , Medical Oncology/methods , Observational Studies as Topic/methods , Research Design , Humans
14.
J Trauma Acute Care Surg ; 80(2): 237-42, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26813298

ABSTRACT

BACKGROUND: Damage-control laparotomy (DCL) is a lifesaving operation used in critically ill patients; however, interval primary fascial closure remains a challenge. We hypothesized that flaccid paralysis of the lateral abdominal wall musculature induced by botulinum toxin A (BTX) would improve rates of primary fascial closure, decrease duration of hospital stay, and enhance pain control. METHODS: Consenting adults who had undergone a DCL at two institutions were prospectively randomized to receive ultrasound-guided injections of their external oblique, internal oblique, and transversus abdominus muscles with either BTX (150 mL, 2 U/mL) or placebo (150-mL 0.9% NaCl). Patients were excluded if they had a body mass index of greater than 50, remained unstable or coagulopathic, were home O2 dependent, or had an existing neuromuscular disorder. Outcomes were assessed in a double-blinded manner. Univariate and Kaplan-Meier estimates of cumulative probability of abdominal closure were performed. RESULTS: We randomized 46 patients (24 BTX, 22 placebo). There were no significant differences in demographics, comorbidities, and physiologic status. Injections were performed on average 1.8 ± 2.8 days (range, 0-14 days) after DCL. The 10-day cumulative probability of primary fascial closure was similar between groups: 96% for BTX (95% confidence interval [CI], 72-99%) and 93% for placebo (95% CI, 61-99%) (HR, 1.0; 95% CI, 0.5-1.8). No difference between BTX and placebo groups was observed for hospital length of stay (37 days vs. 26 days, p = 0.30) or intensive care unit length of stay (17 days vs. 11 days, p = 0.27). There was no difference in median morphine equivalents following DCL. The overall complication rate was similar (63% vs. 68%, p = 0.69), with two deaths in the placebo group and none in the BTX group. No BTX or injection procedure complications were observed. CONCLUSION: The use of BTX after DCL was safe but did not seem to affect primary fascial closure, hospital length of stay, or pain modulation after DCL. Given higher-than-expected rates of primary fascial closure, Type II error may have occurred. LEVEL OF EVIDENCE: Therapeutic study, level III.


Subject(s)
Abdominal Muscles , Abdominal Wound Closure Techniques , Acetylcholine Release Inhibitors/therapeutic use , Botulinum Toxins, Type A/therapeutic use , Laparotomy/adverse effects , Pain, Postoperative/prevention & control , Abdominal Wall , Aged , Female , Humans , Injections, Intramuscular , Length of Stay , Male , Middle Aged , Pain, Postoperative/etiology , Paralysis/chemically induced , Pilot Projects , Prospective Studies , Wound Healing
15.
Inflamm Bowel Dis ; 19(12): 2644-51, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24105393

ABSTRACT

BACKGROUND: Data on the differences in inpatient treatment approaches and outcomes between younger and older patients with inflammatory bowel disease (IBD) are limited. Therefore, we used a parallel cohort study design to compare outcomes between younger and older patients with IBD. METHODS: All anti-tumor necrosis factor (TNF)-naive patients aged 60 years and older hospitalized at our institution between 2003 and 2011 and treated with corticosteroids for an IBD flare were matched 1:1 to younger patients aged 18 to 50 years. Rates of corticosteroid response, colectomy, and initiation of anti-TNF therapy were compared. RESULTS: Sixty-five patients were identified in each cohort. Median ages were 70 years (range, 60-94) and 30 years (range, 18-50) for the older and younger groups, respectively. Twenty-three percent of older patients were refractory to corticosteroids compared with 38% of the younger cohort (odds ratio, 0.5; 95% confidence intervals, 0.2-1.1). Older corticosteroid-refractory patients had surgery (80% versus 72%) and were started on anti-TNF therapy (20% versus 12%; P = 0.71), at a similar frequency as younger patients. Older steroid-responsive patients were less likely to start an anti-TNF agent during the first year of follow-up than younger patients (7% versus 31%, P = 0.006), but there was no difference in 1-year colectomy rates (27% versus 28%, P = 0.63). CONCLUSIONS: Corticosteroid response was similar in older and younger patients hospitalized for IBD. Inpatient treatment for corticosteroid-refractory patients was similar between cohorts. Older corticosteroid-responsive patients were less likely to be treated with an anti-TNF than younger patients.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Hospitalization/statistics & numerical data , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Case-Control Studies , Child , Female , Follow-Up Studies , Humans , Male , Medical Records , Middle Aged , Prognosis , Young Adult
16.
J Arthroplasty ; 22(6 Suppl 2): 100-5, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17823026

ABSTRACT

From 1989 to 1994, 72 patients (73 knees) were treated for an aseptic, failed primary total knee arthroplasty (TKA) at 1 institution with revision TKA using a posterior stabilized implant of 1 design with modular, fully cemented femoral and tibial stems. There were 70 knees in 69 patients followed for a minimum of 2 years, or until component rerevision or resection. The remaining 3 patients died or were followed up for less than 2 years. The median follow-up of living patients with retained components was 10.2 years. Four knees had both femoral and tibial components rerevised for aseptic loosening. One knee was rerevised for patellar loosening and polyethylene wear. Five- and 10-year implant survivorship free of revision for aseptic failure was 98% and 92%, respectively.


Subject(s)
Arthroplasty, Replacement, Knee/instrumentation , Knee Prosthesis , Aged , Aged, 80 and over , Bone Cements , Female , Follow-Up Studies , Humans , Knee Joint/diagnostic imaging , Knee Joint/physiology , Male , Middle Aged , Prosthesis Design , Prosthesis Failure , Radiography , Range of Motion, Articular , Reoperation
17.
Int Orthop ; 28(4): 206-10, 2004 Aug.
Article in English | MEDLINE | ID: mdl-15118841

ABSTRACT

We compared the clinical and radiographic results of two matched series of total hip arthroplasties, one with hydroxyapatite-coated femoral stems, the other with a similar but porous-coated femoral stem. The prevalence of radiographic osteolysis was 16% in hips with hydroxyapatite-coated stems and 43% in hips with porous-coated femoral stems. In hips with hydroxyapatite-coated stems, osteolysis was always limited to Gruen zones 1 and 7. In contrast, distal osteolysis was present around 26% of the porous-coated stems. At 7 years, the survival-free rate of distal osteolysis was 100% in hips with hydroxyapatite-coated stems but 90% in hips with porous-coated stems (p=0.04). Circumferential hydroxyapatite coating of the femoral component reduced the occurrence of osteolysis and eliminated distal osteolysis at 5-10 years of follow-up. In addition, hydroxyapatite coating did not alter the wear rate.


Subject(s)
Arthroplasty, Replacement, Hip/methods , Femur/surgery , Hip Prosthesis , Osteolysis/epidemiology , Adult , Aged , Coated Materials, Biocompatible , Durapatite , Female , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , Prosthesis Failure , Reoperation , Survival Analysis
18.
AJR Am J Roentgenol ; 178(2): 283-90, 2002 Feb.
Article in English | MEDLINE | ID: mdl-11804881

ABSTRACT

OBJECTIVE: Contrast-enhanced CT colonography has the potential to detect local recurrence, metachronous disease, and distant metastases in patients with a history of invasive colorectal cancer. The purpose of our study was to determine whether colonic anastomoses prohibit adequate colonic distention on contrast-enhanced CT colonography and to estimate the performance of contrast-enhanced CT colonography in detecting recurrent colorectal carcinoma. MATERIALS AND METHODS: Fifty patients with a history of resected invasive colorectal carcinoma underwent contrast-enhanced CT colonography and colonoscopy. Colonic distention was graded for different colonic segments. Two radiologists evaluated for the presence of local recurrence, metachronous disease, and metastatic disease. Results were compared with colonoscopy, histology, and clinical follow-up. RESULTS: Most patients had adequate colonic inflation (37/50, 74%). Eleven of 13 patients with inadequate distention had collapse in the sigmoid colon, usually associated with ileocolic anastomoses. Contrast-enhanced CT colonography detected local recurrences with an accuracy of 94% (95% confidence interval, 83-99%). The accuracy of contrast-enhanced CT colonography for metachronous lesions greater than or equal to 1 cm was 92% (95% confidence interval, 80-98%), but there was only one such lesion, which was missed on initial colonoscopy. Stool, granulation tissue, and inflammation can mimic the CT appearance of local recurrence or metachronous disease and account for false-positive examinations. Contrast-enhanced CT colonography identified five patients with metastatic disease. CONCLUSION: Suboptimal sigmoid distention can be seen on contrast-enhanced CT colonography, predominantly in patients with right hemicolectomies. Contrast-enhanced CT colonography is a promising method for detecting local recurrence, metachronous disease, and distant metastases in patients with prior invasive colorectal carcinoma. The technique can also serve as a useful adjunct to colonoscopy by detecting local recurrences or metachronous disease that are endoscopically obscure or by serving as a full structural colonic examination when endoscopy is incomplete.


Subject(s)
Colonography, Computed Tomographic , Colorectal Neoplasms/diagnostic imaging , Neoplasm Recurrence, Local/diagnostic imaging , Adult , Aged , Aged, 80 and over , Colorectal Neoplasms/pathology , Feasibility Studies , Female , Humans , Middle Aged , Neoplasm Metastasis , Time Factors
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