Anti-Saccharomyces cerevisiae antibody (ASCA) positivity is associated with increased risk for early surgery in Crohn's disease

BACKGROUND: Anti-Saccharomyces cerevisiae antibodies (ASCA) are a specific but only moderately sensitive diagnostic marker for Crohn's disease. We sought to explore the role of ASCA as a prognostic marker for aggressive disease phenotype in Crohn's disease. AIMS: To determine the role of ASCA status as a risk factor for early surgery in Crohn's disease. SUBJECTS: We performed a case control study in a cohort of patients, newly diagnosed with Crohn's disease, between 1991 and 1999. All patients were followed for at least three years. Case subjects (n = 35) included those who had major surgery for Crohn's disease within three years of diagnosis. Controls (n = 35) included patients matched to cases for age, sex, disease location, and smoking status, and who did not undergo major surgery for Crohn's disease within three years of diagnosis. METHODS: Blinded assays were performed on serum for ASCA (immunoglobulin (Ig)A and IgG). A paired analysis of cases-controls was performed to test for the association between ASCA status and risk of early surgery. RESULTS: ASCA IgA was strongly associated with early surgery (odds ratio (OR) 8.5 (95% confidence interval (CI) 2.0-75.9); p = 0.0013). ASCA IgG+ and ASCA IgG+/IgA+ patients were also at increased risk for early surgery (OR 5.5 (95% CI 1.2-51.1), p = 0.0265; and OR 5.0 (95% CI 1.1-46.9), p = 0.0433, respectively). The association between ASCA and early surgery was evident in patients requiring surgery for ileal or ileocolonic disease. CONCLUSIONS: Patients with Crohn's disease who are positive for ASCA IgA, IgG, or both, may define a subset of patients with Crohn's disease at increased risk for early surgery.     

Preventing Intra-Abdominal Adhesions With Polylactic Acid Film: An Animal Study

PURPOSE The aim of this study was to evaluate the efficacy of an absorbable polylactic acid film (SurgiWrap^TM) in preventing postoperative intra-abdominal adhesions in an animal model.METHODS Forty-four female Sprague-Dawley rats underwent laparotomy with subsequent cecal wall abrasion and abdominal wall injury. Rats were divided equally between untreated and treated groups. Treated rats had a polylactic acid film (SurgiWrap^TM) placed between the cecal and abdominal wall defects. Rats in the untreated group received no barrier material. The animals were killed on postoperative day 21. Two blinded observers, using predetermined criteria, graded the cecum-to-abdominal wall adhesions and estimated the percent of cecal surface area involved in the adhesion. The adhesions were classified as absent, moderate, or severe.RESULTS Four rats died postoperatively. Of surviving rats, all of the rats in the untreated group had cecum-to-abdominal wall adhesions, whereas 42.1 percent of rats in the treated group had no adhesions between the cecum and the abdominal wall (two-tailed, P = 0.001). Altogether, 28.6 percent and 71.4 percent of untreated rats experienced moderate and severe adhesions, respectively, compared to 47.4 percent and 10.5 percent of treated rats (two-tailed, P < 0.001).CONCLUSIONS Strategic placement of polylactic acid film during abdominal surgery is associated with a significantly reduced rate and severity of postoperative intra-abdominal adhesions in this model. A technique for film placement is suggested.Macropore Biosurgery, Inc. supported this work.Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Dallas, Texas, May 9 to 13, 2004.     

What can hospitalized patients tell us about adverse events? Learning from patient-reported incidents

PURPOSE: Little is known about how well hospitalized patients can identify errors or injuries in their care. Accordingly, the purpose of this study was to elicit incident reports from hospital inpatients in order to identify and characterize adverse events and near-miss errors. SUBJECTS: We conducted a prospective cohort study of 228 adult inpatients on a medicine unit of a Boston teaching hospital. METHODS: Investigators reviewed medical records and interviewed patients during the hospitalization and by telephone 10 days after discharge about "problems,"mistakes," and "injuries" that occurred. Physician investigators classified patients' reports. We calculated event rates and used multivariable Poisson regression models to examine the factors associated with patient-reported events. RESULTS: Of 264 eligible patients, 228 (86%) agreed to participate and completed 528 interviews. Seventeen patients (8%) experienced 20 adverse events; 1 was serious. Eight patients (4%) experienced 13 near misses; 5 were serious or life threatening. Eleven (55%) of 20 adverse events and 4 (31%) of 13 near misses were documented in the medical record, but none were found in the hospital incident reporting system. Patients with 3 or more drug allergies were more likely to report errors compared with patients without drug allergies (incidence rate ratio 4.7, 95% CI 1.7, 13.4). CONCLUSION: Inpatients can identify adverse events affecting their care. Many patient-identified events are not captured by the hospital incident reporting system or recorded in the medical record. Engaging hospitalized patients as partners in identifying medical errors and injuries is a potentially promising approach for enhancing patient safety.     

Second marrow transplants in patients with aplastic anemia rejecting the first graft: use of a conditioning regimen including cyclophosphamide and antithymocyte globulin

Sixteen (11%) of 146 consecutive patients with severe aplastic anemia prepared for engraftment with cyclophosphamide (200 mg/kg) rejected marrow grafts from their HLA-identical siblings. They were given a second marrow transplant from either the same (n = 13) or a second (n = 3) HLA-identical sibling between 23 and 743 (median 86) days after the first transplant. The preparation for the second transplant included cyclophosphamide, 50 mg/kg, on each of four successive days. Twelve hours after each of the first three doses of cyclophosphamide, antithymocyte globulin, 30 mg/kg/dose, was infused. One of the 16 patients died from infection too early after the second transplant to be evaluated, two had failure of engraftment and died with infection, one rejected the second graft and is surviving almost 5 years later with full autologous marrow recovery, and 12 had successful and sustained second grafts. Of these 12, six are surviving between 11 months and 7 3/4 years. Four of the six have no graft-v-host disease (GVHD), while two have chronic GVHD requiring treatment. Five have Karnofsky scores of 100% and one of 90%. Six of the 12 patients with sustained grafts died between 63 days and 38 months after transplantation, four with infections (related in two patients to chronic GVHD), one with acute GVHD, and one with hemorrhage. The average interval from first to second transplant was 308 days during the past five years, compared to 61 days in earlier patients. Five of seven recent patients are surviving, compared to two of nine earlier patients. In conclusion, successful second transplants after cyclophosphamide and antithymocyte globulin are possible in most patients with aplastic anemia who have rejected their first marrow grafts; however, mortality remains high, with only 40% of the patients becoming long-term survivors.     

Risk factors for colon ischemia

BACKGROUND: To identify predictors of colon ischemia, we examined demographic and clinical characteristics of patients, as well as their prior health care utilization. METHODS: Using insurance data, we identified 700 persons at least 20-yr old with presumed colon ischemia between 1995 and 1999, and 6,440 controls. Case identification was based on diagnosis and procedure codes in insurance claims for which we used a previously reported, validated algorithm. We ascertained preceding medical diagnoses and the use of drugs and health services from the insurance claims files. RESULTS: Patients with colon ischemia were nearly three times as likely to have IBS than controls. A history of nonspecific colitis, lower gastrointestinal tract hemorrhage, systemic rheumatologic disorders, and ischemic heart disease in the preceding 6 months, and abdominal surgery in the past month were also much more common in colon ischemia cases than controls. Use of a drug to treat diarrhea was strongly associated with risk. The most prevalent risk factor for colon ischemia was the use of drugs with a side effect of constipation, found in one-third of cases and one in nine controls. Cases had seen physicians, particularly gastroenterologists, much more commonly in the preceding 6 months than had controls. CONCLUSIONS: Clinically evident colon ischemia arises preferentially in persons with prior abdominal complaints, many of whom carry a diagnosis of IBS. Drugs that reduce bowel motility may constitute a widespread and potentially avoidable risk factor. The frequency of preceding doctor visits, without a specific diagnosis, suggests that colon ischemia may have a prolonged subacute presentation.     

A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures

PURPOSE: The aim of this study was to determine the optimal dose and dosing interval of nitroglycerin ointment to heal chronic anal fissures. METHOD: A randomized, double-blind study of intra-anally applied nitroglycerin ointment (Anogesic) was conducted in 17 centers in 304 patients with chronic anal fissures. The patients were randomly assigned to one of eight treatment regimens (0.0, 0.1, 0.2, 0.4 percent nitroglycerin ointment applied twice or three times per day), for up to eight weeks. A dose-measuring device standardized the delivery of 374 mg ointment. Healing of fissures (complete reepithelialization) was assessed by physical examination using an observer unaware of treatment allocation. The subjects assessed pain intensity daily by completing a diary containing a visual analog scale for average pain intensity for the day, the worst pain intensity for the day, and pain intensity at the last defecation. RESULTS: There were no significant differences in fissure healing among any of the treatment groups; all groups, including placebo had a healing rate of approximately 50 percent. This rate of placebo response was inexplicably higher than previously reported in the literature. Treatment with 0.4 percent (1.5 mg) nitroglycerin ointment was associated with a significant (P < 0.0002) decrease in average pain intensity compared with vehicle as assessed by patients with a visual analog scale. The decreases were observed by Day 4 of treatment. At 8 weeks the magnitude of the difference between 0.4 percent nitroglycerin and control was a 21 percent reduction in average pain. Treatment was well tolerated, with only 3.29 percent of patients discontinuing treatment because of headache. Headaches were the primary adverse event and were dose related. CONCLUSION: Nitroglycerin ointment did not alter healing but significantly and rapidly reduced the pain associated with chronic anal fissures.     

Marrow harvesting from normal donors

The experience at a single institution in harvesting marrow for allogeneic transplantation on 1,270 occasions from 1,160 normal donors is presented in detail, together with an analysis of all the donor complications. Four donors were less than 2 years old, and the youngest was 6 1/2 months. No special difficulties were encountered with these young donors. Hospitalization time was three days or less for 99% of the procedures. Six donors had life-threatening complications; three of a cardiopulmonary and two of an infectious nature, and one cerebrovascular embolic episode. Significant operative site morbidity, usually transient neuropathies, occurred in ten procedures. Ten percent of the donations were associated with transient postoperative fever of unknown origin. Increasing donor age was associated with a reduction of the cellularity of the marrow harvest. The use of stored autologous blood permitted the avoidance of blood bank transfusion in 81% of males, 69% of females, and 50% of children. It was concluded that the procedure was associated with a very low risk of complication, but that the involvement of normal donors in such an operation justifies stringent monitoring.