Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study.

OBJECTIVE: To prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events. DESIGN: International, multicentre cohort study. SETTING: 18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America. PARTICIPANTS: The cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres. MAIN OUTCOME MEASURES: Intraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications. RESULTS: Of 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0.99 (95% confidence interval 0.69 to 1.42); grade II versus grade 0, 1.39 (0.97 to 2.00); grade III versus grade 0, 2.62 (1.31 to 5.26); and grade IV versus grade 0, 3.81 (1.19 to 12.2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0.76 (95% confidence interval 0.59 to 0.91) in the survey (response rate 83%). CONCLUSIONS: ClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03009929.

The effects of preoperative oral antibiotic use on the development of surgical site infection after elective colorectal resections: A retrospective cohort analysis in consecutively operated 90 patients.

PURPOSE: The influence of oral antibiotic use together with mechanical bowel preparation (MBP) on surgical site infection (SSI) rate, length of hospital stay and total hospital costs in patients undergoing elective colorectal surgery were evaluated in this study. METHODS: Data from 90 consecutive patients undergoing elective colorectal resection between October 2006 and September 2009 was analyzed retrospectively. All patients received MBP. Patients in group A were given oral antibiotics (a total 480 mg of gentamycin, 4 gr of metronidazole in two divided doses and 2 mg of bisacodyl PO), whereas patients in group B received no oral antibiotics. Exclusion criteria were emergent operations, laparoscopic operations, preoperative chemoradiotherapy, intraoperative colonoscopy prior to the creation of an anastomosis or antibiotic use within the previous 10 days. SSI, length of hospital stays and total hospital charges were evaluated. RESULTS: Patients in both study groups, group A (n = 45) and group B (n = 45), were similar in terms of age, BMI, diverting ileostomy creation, localization and stage of the disease. Patients receiving oral antibiotics demonstrated a lower rate of wound infections (36% vs. 71%, p < 0.001), shorter hospital stay (8.1 ± 2.4 days vs. 14.2 ± 10.9 days, respectively, p < 0.001) and similar rates for anastomotic leakage (2% vs. 11%, p = 0.20). The mean ± SD total hospital charges were significantly lower in Group A (2.699 ± 0.892$) than that in Group B (4.411 ± 4.995$, p = 0.029). CONCLUSION: Preoperative oral antibiotic use with MBP may provide faster recovery with less SSI and hospital charges.