Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment.

INTRODUCTION: Several European studies suggest that some patients with appendicitis can be treated safely with antibiotics. A portion of patients eventually undergo appendectomy within a year, with 10%-15% failing to respond in the initial period and a similar additional proportion with suspected recurrent episodes requiring appendectomy. Nearly all patients with appendicitis in the USA are still treated with surgery. A rigorous comparative effectiveness trial in the USA that is sufficiently large and pragmatic to incorporate usual variations in care and measures the patient experience is needed to determine whether antibiotics are as good as appendectomy. OBJECTIVES: The Comparing Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial for acute appendicitis aims to determine whether the antibiotic treatment strategy is non-inferior to appendectomy. METHODS/ANALYSIS: CODA is a randomised, pragmatic non-inferiority trial that aims to recruit 1552 English-speaking and Spanish-speaking adults with imaging-confirmed appendicitis. Participants are randomised to appendectomy or 10 days of antibiotics (including an option for complete outpatient therapy). A total of 500 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary analytic outcome is quality of life (measured by the EuroQol five dimension index) at 4 weeks. Clinical adverse events, rate of eventual appendectomy, decisional regret, return to work/school, work productivity and healthcare utilisation will be compared. Planned exploratory analyses will identify subpopulations that may have a differential risk of eventual appendectomy in the antibiotic treatment arm. ETHICS AND DISSEMINATION: This trial was approved by the University of Washington's Human Subjects Division. Results from this trial will be presented in international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02800785.

Ligation of Intersphincteric Fistula Tract: a Sphincter-Sparing Option for Complex Fistula-in-Ano.

Fistulae-in-ano represent one of the more challenging anorectal diseases faced by surgeons, as appropriate management requires careful balance between the need for local sepsis control and patients' desire to maintain fecal continence. The ligation of intersphincteric fistula tract (LIFT) procedure, first described by Rojanasakul and colleagues in 2007, represents a sphincter-sparing technique for fistula management which has become our method of choice for transsphincteric fistulas. With this technique, patients frequently enjoy successful fistula healing., or, at worst, conversion to a less complex fistula tract. Here, we describe and illustrate our surgical approach and review success and recurrence rates presented in the published literature.

Relationship between model for end-stage liver disease score and 30-day outcomes for patients undergoing elective colorectal resections: an American college of surgeons-national surgical quality improvement program study.

BACKGROUND: Patients with liver disease face significant risk of complications and death when considering elective colorectal resection for benign or malignant indications. OBJECTIVE: We sought to determine the relationship between Model of End-Stage Liver Disease score and 30-day outcomes in patients undergoing elective colorectal resections. DESIGN: This was a retrospective cohort study. SETTINGS: The study included hospitals participating in the National Surgical Quality Improvement Program. PATIENTS: Adult patients who underwent elective colorectal resection from 2005 to 2011 were identified from the National Surgical Quality Improvement Program database. Patients missing laboratory values necessary to calculate the Model of End-Stage Liver Disease score were excluded (61% of 81,346 patients identified). MAIN OUTCOME MEASURES: Differences in patient- and disease-related characteristics by Model of End-Stage Liver Disease categories were assessed with χ analyses. Thirty-day mortality and major morbidity were examined using logistic regression. RESULTS: Of 31,950 patients undergoing elective colorectal resections (14% including proctectomy), most (60%) were performed for colon or rectal cancer; other benign indications included diverticulitis (20%), polyp (10%), and IBD (10%). A total of 58% of patients had a Model of End-Stage Liver Disease score of ≥7. Increasing scores were associated with older age; higher BMI; higher ASA class; lower albumin level; and higher incidence of diabetes mellitus, pulmonary and cardiac disease, hypertension, and dependent functional status. In univariate analysis, patients with higher scores had a greater risk of 30-day mortality (score = 6 (0.69%); 7-11 (1.62%); 11-15 (4.52%); >15, (5.01%); p < 0.0001). After controlling for other comorbidities, Model of End-Stage Liver Disease score remained a significant predictor of 30-day mortality, major complications, and respiratory complications. LIMITATIONS: This was a retrospective analysis of administrative data, limiting some access to clinically relevant data. CONCLUSIONS: Consistent with previous reports, patients with higher Model of End-Stage Liver Disease scores have a significantly higher risk of death and major morbidity in the 30 days after elective colorectal resection (see Video, Supplemental Digital Content, http://links.lww.com/DCR/A180).

Adjuvant chemotherapy for stage II right-sided and left-sided colon cancer: analysis of SEER-medicare data.

BACKGROUND: Survival benefit from adjuvant chemotherapy is established for stage III colon cancer; however, uncertainty exists for stage II patients. Tumor heterogeneity, specifically microsatellite instability (MSI), which is more common in right-sided cancers, may be the reason for this observation. We examined the relationship between adjuvant chemotherapy and overall 5-year mortality for stage II colon cancer by location (right- vs left-side) as a surrogate for MSI. METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified Medicare beneficiaries from 1992 to 2005 with AJCC stage II (n = 23,578) and III (n = 17,148) primary adenocarcinoma of the colon who underwent surgery for curative intent. Overall 5-year mortality was examined with Kaplan-Meier survival analysis and Cox proportional hazards regression with propensity score weighting. RESULTS: It was found that 18 % of stage II patients (n = 2941) with right-sided cancer and 22 % (n = 1693) with left-sided cancer received adjuvant chemotherapy. After adjustment, overall 5-year survival benefit from chemotherapy was observed only for stage III patients (right-sided: hazard ratio [HR], 0.64; 95 % CI, 0.59-0.68; p < .001 and left-sided: HR, 0.61; 95 % CI, 0.56-0.68; p < .001). No survival benefit was observed for stage II patients with either right-sided (HR, 0.97; 95 % CI, 0.87-1.09; p = .64) or left-sided cancer (HR, 0.97; 95 % CI, 0.84-1.12; p = .68). CONCLUSIONS: Among Medicare patients with stage II colon cancer, a substantial number receive adjuvant chemotherapy. Adjuvant chemotherapy did not improve overall 5-year survival for either right- or left-sided colon cancers. Our results reinforce existing guidelines and should be considered in treatment algorithms for older adults with stage II colon cancer.