Robert K. Cleary

Clostridium Difficile-Associated Diarrhea and Colitis

PURPOSE: This review examines the pathogenesis, clinical manifestations, diagnosis, and current medical and operative strategies in the treatment ofClostridium difficile diarrhea and colitis. Prevention and future avenues of research are also investigated. METHODS: A review of the literature was conducted with the use of MEDLINE. RESULTS:C. difficile is a gram-positive, spore-forming bacterium capable of causing toxigenic colitis in susceptible patients, usually those receiving antibiotics. Overgrowth of toxigenic strains may result in a spectrum of disease, including becoming an asymptomatic carrier, diarrhea, self-limited colitis, fulminant colitis, and toxic megacolon. Diagnosis requires a high index of suspicion and depends on clinical data, laboratory stool studies (enzyme-linked immunoabsorbent assay and cytotoxin test), and endoscopy in selected cases. Protocols for treatment of primary and relapsing infections are provided in algorithm format. Discontinuation of antibiotics may be enough to resolve symptoms. Medical management with oral metronidazole or vancomycin is the first-line therapy for those with symptomatic colitis. Teicoplanin,Saccharomyces spp. andLactobacillus spp., and intravenous IgG antitoxin are reserved for more recalcitrant cases. Refractory or relapsing infections may require vancomycin given orally or other newer modalities. Fulminant colitis and toxic megacolon warrant subtotal colectomy. Cost, in terms of extended hospital stay, medical and surgical management, and, in some cases, ward closure, is thought to be formidable. Review of perioperative antibiotic policies and analysis of hospital formularies may contribute to prevention and decreased costs. CONCLUSION:C. difficile diarrhea and colitis is a nosocomial infection that may result in significant morbidity, mortality, and medical costs. Standard laboratory studies and endoscopic evaluation assist in the diagnosis of clinically suspicious cases. Appropriate perioperative antibiotic dosing, narrowing the antibiotic spectrum when treating infections, and discontinuing antibiotics at appropriate intervals prevent toxic sequelae.

Antibiotic choice is independently associated with risk of surgical site infection after colectomy: A population-based cohort study

Objective: To determine which perioperative care practices are associated with decreased risk of surgical site infection (SSI) after colectomy surgery. Background: Optimization of perioperative care has been a common strategy for improving surgical safety, but the relationship between process measure compliance and surgical complication rates is controversial. Methods: This is a retrospective cohort study performed within the Michigan Surgical Quality Collaborative (MSQC), an organization of hospitals that prospectively collects patient data, processes of care, and 30-day outcomes. Patients undergoing colectomy surgery (n = 4331) were studied. Factors potentially associated with SSI were tested using univariate statistical tests, and a hierarchical generalized linear model was created to test for independent associations between processes of care and SSI, while adjusting for patient risk factors and clustering of patients within hospitals. Results: Several perioperative care practices were independently associated with lower risk of SSI after adjustment for patient risk, procedure type/duration, and clustering of patients by hospital site. Best practices include selection of a Surgical Care Improvement Project (SCIP-2)-compliant prophylactic intravenous antibiotic, postoperative normothermia, postoperative day 1 glucose control, and oral antibiotics given when bowel prep used (SCIP-1 was not significant). Further, several specific prophylactic antibiotic choices were independently associated with lower SSI rates, including cefazolin/metronidazole, ciprofloxacin/metronidazole, and ertapenem. Conclusions: In Michigan, several perioperative care practices are independently associated with decreased risk of SSI after colectomy, including SCIP-2-compliant prophylactic antibiotics, postoperative normothermia, glucose control, and oral antibiotics. Furthermore, specific prophylactic antibiotic choices are associated with lower risk of SSI. These results account for patient factors and unmeasured hospital effects, suggesting that dissemination of these perioperative care practices may decrease SSI rates.

Perianal bowen's disease and anal intraepithelial neoplasia

PURPOSE: The aim of this study was to review the literature with regard to perianal Bowens disease and anal intraepithelial neoplasia. METHODS: A literature review was conducted from 1960 to 1999 using MEDLINE. RESULTS: Perianal Bowens disease and anal intraepithelial neoplasia are precursors to squamous carcinoma of the anus. They are analogous to and are associated with cervical and vulvar intraepithelial neoplasia, and have human papillomavirus as a common cause. Biopsy and histopathologic examination is required for diagnosis and to distinguish other perianal dermatoses. Treatment options range from aggressive wide local excision of all disease with negative margins to observation alone for microscopic lesions not visible to the naked eye. The disease has a proclivity for recurrence and recalcitrance. CONCLUSIONS: Most surgeons caring for patients with perianal Bowens disease and high-grade anal epithelial neoplasia use wide local excision, with an effort to obtain disease-free margins. Some authors have reported the advantages of ablative procedures such as laser ablation and cryotherapy. Microscopic disease found serendipitously in hemorrhoidectomy specimens can probably be treated conservatively with serial examinations alone. There is a lack of controlled data supporting an optimal treatment strategy. A multicenter controlled study comparing wide local excision with ablative procedures may be warranted.

Risk factors for anastomotic leakage after colectomy.

BACKGROUND: Anastomotic leakage is a morbid and potentially fatal complication of colorectal surgery. Determination of pre- and intraoperative risk factors may identify patients requiring increased postoperative surveillance for this major complication. OBJECTIVE: The purpose of this study was to identify risk factors associated with anastomotic leakage after colectomy with primary intra-abdominal anastomosis. DESIGN: The prospective, statewide multicenter Michigan Surgical Quality Collaborative database was analyzed. SETTING: This study was performed at academic and community medical centers in the state of Michigan. PATIENTS: Included were all cases of open and laparoscopic colectomy with primary intra-abdominal anastomosis from 2007 through 2010. MAIN OUTCOME MEASURES: Univariate analysis followed by a multivariate logistic regression model was used to determine the influence of patient factors and operative events with respect to the incidence of postoperative anastomotic leakage. RESULTS: Inclusion criteria were met by 4340 cases. Anastomotic leakage occurred in 85 (3.2%) of the 2626 (60.5%) open colectomies, and in 51 (3.0%) of the 1714 (39.5%) laparoscopic procedures, which was not significantly different (p = 0.63). Significant risk factors associated with anastomotic leakage based on the multivariate logistic regression model were fecal contamination with OR 2.51, 95% CI, 1.16 to 5.45, p = 0.02; and intraoperative blood loss of more than 100 mL and 300 mL, with OR 1.62, 95% CI, 1.10 to 2.40, p = 0.02; and OR 2.22, 95% CI, 1.32 to 3.76, p = 0.003. LIMITATIONS: The Michigan Surgical Quality Collaborative colectomy project excluded high-risk rectal resections and low pelvic anastomoses. Information about operative technique and intraoperative events is limited, and anastomotic leakage was determined through chart review. CONCLUSION: Fecal contamination and increased blood loss during colectomy should raise suspicion for potential postoperative anastomotic leakage.

Nonsteroidal Anti-inflammatory Drugs: Do They Increase the Risk of Anastomotic Leaks Following Colorectal Operations?

BACKGROUND: Nonsteroidal anti-inflammatory drugs have become an important component of narcotic-sparing postoperative pain management protocols. However, conflicting evidence exists regarding the adverse association of nonsteroidal anti-inflammatory drug use with intestinal anastomotic healing in colorectal surgery. OBJECTIVE: This study compares patients receiving nonsteroidal anti-inflammatory drugs on postoperative day 1 with patients who did not receive nonsteroidal anti-inflammatory drugs with regard to the occurrence of anastomotic leaks. DESIGN: This is a retrospective study from a protocol-driven prospectively collected statewide database. A propensity score model was used to adjust for differences between the groups in patient demographics, characteristics, comorbidities, and laboratory values. SETTINGS: The multicenter data set used in this analysis represents a variety of academic and community hospitals within the state of Michigan from July 2012 through February 2014. PATIENTS: Nonpregnant patients over the age of 18 who underwent colon and rectal surgery with bowel anastomosis were selected. MAIN OUTCOME MEASURES: Occurrence of anastomotic leak, composite surgical site infection, sepsis, and death within 30 days of surgery were the primary outcomes measured. RESULTS: A total of 4360 patients met inclusion criteria, of which 1297 (29.7%) received nonsteroidal anti-inflammatory drugs and 3063 (70.3%) did not receive nonsteroidal anti-inflammatory drugs. There was no statistically significant difference between the 2 groups in the proportion of cases with anastomotic leak (OR, 1.33; CI, 0.86–2.05; p = 0.20), composite surgical site infection (OR, 1.26; CI, 0.96–1.66; p = 0.09), or death within 30 days (OR, 0.58; CI, 0.28–1.19; p = 0.14). There was a significantly greater risk of sepsis for patients given nonsteroidal anti-inflammatory drugs than for those patients not given nonsteroidal anti-inflammatory drugs (OR, 1.47; CI, 1.05–2.06; p = 0.03). LIMITATIONS: This is a nonrandomized study performed retrospectively, and it is based on data collected only within a subset of hospitals in the state of Michigan. CONCLUSIONS: No statistically significant increase in the proportion of patients with anastomotic leak was observed when prescribing nonsteroidal anti-inflammatory drugs for analgesia in the early postoperative period for patients undergoing elective colorectal surgery. Unexpectedly, there was an increased risk of sepsis that warrants further investigation (see video, Supplemental Digital Content 1, http://links.lww.com/DCR/A192, for a synopsis of this study).

Risk factors for readmission after elective colectomy: postoperative complications are more important than patient and operative factors.

BACKGROUND: Colon resections are associated with substantial risk for morbidity and readmissions, and these have become markers for quality of care. OBJECTIVE: The purpose of this study was to determine risk factors for readmissions after elective colectomies to improve patient care and better understand the complex issues associated with readmissions. DESIGN: This was an analysis of the prospective, statewide, multicenter Michigan Surgical Quality Collaborative database. SETTINGS: The analysis was conducted at academic and community medical centers in the state of Michigan. PATIENTS: Elective laparoscopic and open ileocolic and segmental colectomies from 2008 through 2010 were included. MAIN OUTCOME MEASURES: Univariate analysis and a multivariate logistic regression model were used to determine influence of patient characteristics, operative factors, and postoperative complications on the incidence of 30-day postoperative readmission. RESULTS: The readmission rate among 4013 cases was 7.3% (N = 293). On the basis of multivariate logistic regression, the top 3 significant risk factors associated with readmission were stroke (OR, 10.0 [95% CI, 2.70–37.0]; p = 0.001), venous thromboembolism (OR, 6.5 [95% CI, 3.7–11.3]; p < 0.0001), and organ-space surgical site infection (OR, 5.6 [95% CI, 3.4–9.4]; p < 0.0001). Important factors that contributed to readmission risk but were not found to be independent predictors of readmission included diabetes mellitus, preoperative steroids, smoking, cardiac comorbidities, age >80 years, anastomotic leaks, fascial dehiscence, sepsis, pneumonia, unplanned intubation, and length of stay. LIMITATIONS: The Michigan Surgical Quality Collaborative is a large database, and true causal relations are difficult to determine; reason for readmission is not recorded in the database. CONCLUSIONS: Postoperative complications account for the majority of risk factors behind readmissions after elective colectomy, whereas preoperative risk factors have less direct influence. Current strategies addressing readmission rates should focus on reducing preventable complications.

Metronidazole may inhibit intestinal colonization with Clostridium difficile.

PURPOSE: Antibiotics suppress normal gut flora, allowing overgrowth of acquired or nativeClostridium difficile, with release of toxins that cause mucosal inflammation. Oral metronidazole is used to treat antibiotic-associated colitis (pseudomembranous colitis). This study was designed to determine whether oral metronidazole, as part of preoperative bowel preparation, prevents or decreases incidence of antibiotic-associated colitis after elective colonic and rectal procedures. METHODS: Eighty-two patients (40 men) were prospectively, randomly assigned to receive one of two oral antibiotic regimens before colorectal surgery. All patients underwent mechanical bowel preparation with polyethylene glycol-electrolyte lavage solution before administration of oral antibiotics. Group 1 (n=42) patients received three doses (1 g/dose) of neomycin and erythromycin. Group 2 (n=40) patients received three doses (1 g/dose) of neomycin and metronidazole. Both groups received one preoperative and three postoperative doses of intravenous cefotetan (2 g/dose). Both groups had stool samples tested forC. difficile toxin in the preoperative and postoperative periods by enzyme-linked immunoabsorbent assay or by tissue culture cytotoxicity. Patients with preoperative stool studies positive forC. difficile were excluded from the study. RESULTS: Treatment groups were not different for age, gender, or surgical procedure. Mean age ±1 standard deviation was 67.6±13.6 (range, 34–94) years in Group 1 and 62.1±13.5 (range, 35–84) years in Group 2 (P=0.069). Mean length of hospital stay ±1 standard deviation was 9.76±4.9 (range, 4–28) days for Group 1 and 8.05±2.6 (range, 3–14) days for Group 2 (P=0.053). Five patients in Group 1 (neomycin and erythromycin) and one patient in Group 2 (neomycin and metronidazole) had positive stool studies forC. difficile. Relative risk of colonization withC. difficile in Group 1 was 4.76 times that in Group 2 (95 percent confidence interval, 0.581, 39). This difference was not statistically significant (P=0.202). There were no significant differences inC. difficile colonization rates with respect to age, length of stay, or gender. CONCLUSIONS: This study suggests that there may be a clinical association between use of metronidazole preoperatively and inhibition of intestinal colonization byC. difficile in this patient population undergoing colonic and rectal surgery.

Resident research training conducted in a community hospital general surgery residency program.

PURPOSE Research is educationally important for surgical residents. However, little information exists regarding effective methods for teaching residents scientific methodology in a community hospital. This effort describes an effective program conducted in a community hospital for enhancing scientific opportunities of surgical residents. METHODS A strong infrastructure that supports research is necessary. Dedicated nonsalaried teaching faculty serve as mentors and co-investigators. Opportunities to engage in basic research are made available in off-campus basic science laboratories. RESULTS Research productivity has been prolific, as demonstrated by numerous publications. Residents interested in sub-speciality training have been able to conduct research that has made them competitive for fellowships and a wider range of practice choices. CONCLUSION Rigorous research can be effectively taught in a community hospital, provided adequate educational and funding support is provided and faculty actively mentor residents. Having research capabilities provides added incentive for better-qualified medical students to apply to a surgical residency position in a community hospital. Research productivity also enhances the ability to better recruit new faculty.

Chlorhexidine with isopropyl alcohol versus iodine povacrylex with isopropyl alcohol and alcohol-versus nonalcohol-based skin preparations: The incidence of and readmissions for surgical site infections after colorectal operations

BACKGROUND: Surgical site infections are a major cause of morbidity and mortality after colorectal operations. Preparation of the surgical site with antiseptic solutions is an essential part of wound infection prevention. To date, there is no universal consensus regarding which preparation is most efficacious. OBJECTIVE: This study compared 2.0% chlorhexidine with 70.0% isopropyl alcohol versus 0.7% iodine povacrylex with 74.0% isopropyl alcohol and alcohol-based versus nonalcohol-based skin preparations with regard to efficacy in preventing postoperative wound infections. DESIGN: This is a retrospective study from 2 prospectively collected statewide databases combined. A propensity score model was used to adjust for differences between the groups in patient demographics, characteristics, comorbidities, and laboratory values. SETTINGS: The multicenter data set used in this analysis represents a variety of academic and community hospitals within the state of Michigan from January 2010 through June 2012. PATIENTS: Patients over the age of 18 years who underwent clean-contaminated colorectal operations were included. MAIN OUTCOME MEASURES: The incidence of superficial surgical site infections, any surgical site infection, any wound complication, and readmission within 30 days for surgical site infection were measured. RESULTS: When 2.0% chlorhexidine with 70.0% isopropyl alcohol (n = 425) and 0.7% iodine povacrylex with 74.0% isopropyl alcohol (n = 115) were compared, a total of 540 colorectal cases met inclusion criteria. When alcohol-based (n = 610) and nonalcohol-based (n = 177) skin preparations were compared, a total of 787 colorectal cases met inclusion criteria. There was no significant difference in the propensity-adjusted odds for having any of the 4 outcomes of interest when comparing 2.0% chlorhexidine with 70.0% isopropyl alcohol to 0.7% iodine povacrylex with 74.0% isopropyl alcohol and when comparing alcohol-based with nonalcohol-based skin preparations. LIMITATIONS: This was a nonrandomized study performed retrospectively based on data collected within the state of Michigan. CONCLUSIONS: The use of 2.0% chlorhexidine with 70.0% isopropyl alcohol versus 0.7% iodine povacrylex with 74.0% isopropyl alcohol or alcohol-based versus nonalcohol-based skin preparations does not significantly influence the incidence of surgical site infections or readmission within 30 days for surgical site infection after clean-contaminated colorectal operations.

Patients Prefer Propofol to Midazolam Plus Fentanyl for Sedation for Colonoscopy: Results of a Single-Center Randomized Equivalence Trial.

BACKGROUND: Common sedation options for colonoscopy include propofol alone or a combination of midazolam and fentanyl. The former usually requires the presence of an anesthesia caregiver. The strategy that optimizes patient satisfaction has not yet been determined. OBJECTIVE: This study was designed to assess whether patient satisfaction at the time of colonoscopy is equivalent for propofol compared with midazolam and fentanyl. DESIGN: In this prospective, single-center, parallel group, single-blind, randomized, equivalence trial (NCT-01488045), 262 patients blinded to treatment received propofol (n = 126) or midazolam plus fentanyl (n = 136) at the time of colonoscopy. A patient satisfaction survey was administered in the recovery room and 1 to 5 days postprocedure. The endoscopist completed a survey immediately postprocedure. SETTINGS: This study was conducted at a tertiary academic hospital with a dedicated colon and rectal surgery division. PATIENTS: Patients over the age of 18 years who were undergoing elective colonoscopy were included in this study. MAIN OUTCOME MEASURES: The primary outcome was patient satisfaction with the colonoscopy. Secondary outcomes included physician and patient perception of patient pain, physician perception of patient tolerance of and difficulty of procedure, procedure duration, percentage of patients with cecal intubation, recovery time, and adverse events. RESULTS: Patient overall satisfaction scores in the recovery room after using the combination of midazolam and fentanyl (n = 136) during colonoscopy were not equivalent to patient satisfaction scores after using propofol (n = 126) alone (mean = 83.9 and 98.0 visual analog scale points) because the 90% CI (–18.5 to –9.6) for the mean treatment difference (–14.1) was completely outside the prespecified range of equivalence (±5 visual analog scale points). Patient pain as reported by the patient and as perceived by the physician and difficulty of the procedure were significantly worse for the midazolam/fentanyl group (n = 136) compared with the propofol group (n = 126). Time in the colonoscopy suite was significantly shorter for the propofol group, but the difference was small (4 minutes). There were no significant differences in percentage with cecal intubation, recovery time, or adverse events. LIMITATIONS: This is a single-institution, single-endoscopist study and is limited by the inability to perform blinding of the endoscopist. CONCLUSIONS: The use of propofol for conscious sedation during colonoscopy is associated with greater patient satisfaction and less pain when compared with midazolam/fentanyl, as perceived by the patient and endoscopist.