Recruitment and Patients' Characteristics
During the study period, 453 patients were treated for colonic diverticulitis. According to the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) statement, the flow of participants from group assignment to final analysis is shown in Figure 1. One hundred thirty-two patients met the inclusion criteria and were randomized. Sixty-six patients were allocated in each group. The distribution of patients in the 5 hospitals was similar, without differences between group 1 and 2 randomization.
CONSORT 2010 flow diagram.
Three hundred twenty-one patients were not randomized: 35 patients underwent emergency operations, 160 patients presented complicated diverticulitis at abdominal CT, and 126 patients, even if eligible, did not meet the inclusion criteria. After randomization, 3 patients in group 1 and 1 patient in group 2 refused to follow the assigned treatment of the assigned management. Despite deviation from the protocol and according to the intention-to-treat analysis, these patients were analyzed in the assigned group. Two patients were lost for follow-up, 1 in each group.
Distribution per hospital, age, sex, American Society of Anesthesiologists status, type of abdominal pain (localized or diffuse) at the admission, leukocytes levels, and antibiotic treatment are reported in Table 2. No differences were observed between the 2 groups.
Three patients discontinued participation in the study, 1 patient in group 1 for violation of protocol and 2 patients in group 2 for adverse events.
Seven patients (5.3%) of all the series were readmitted because of failure of medical treatment: 4 patients (6.1%) in group 1 and 3 patients (4.5%) in group 2. No differences were observed between the 2 groups (P = 0.619). No patients needed emergency surgery as a consequence of readmission and no mortality was observed.
Quality-of-life assessment by the SF-12 questionnaire, for physical health and mental health components summary, shows differences inside of each group between the first and the second visits (Table 3). However, no differences were observed between the groups at the visits of days 14 and 60 (Figs. 2 and 3).
Physical health—component summary measure.
Mental health—component summary measure.
Table 4 shows the costs related to each group. The overall health care cost per episode was 3 times lower in group 2 compared with group 1, with savings of [Euro sign]1124.70 per outpatient. This cost is the sum of the total cost of all health care processes including oral antibiotics with which the patient was discharged.