Sadahiro 2014.
Study characteristics | |
Methods |
Study design: Parallel‐group randomised trials Duration of trial: May 2008 to October 2011 Duration of follow‐up: Four weeks Country of origin: Japan |
Participants |
Baseline characteristics
Number randomised: 206 participants
Number analysed: 194 participants
Intervention: MBP+oAB
Control: nBP
Inclusion criteria Quote: "Patients scheduled to undergo elective colon cancer operations in whom curative resection of tumor(s) was considered feasible. The eligibility criteria were as follows: 20‐80 years of age; preoperative performance status of 0 or 1; and no serious coexisting medical conditions." Exclusion criteria Quote: "Patients with a history of intestinal resection, patients with a stoma, patients with intestinal stenosis or obstruction that would preclude routine preoperative mechanical bowel preparation, and patients with stage IV disease on preoperative diagnosis were excluded from this study." Baseline imbalances None |
Interventions |
Comparison
MBP
oAB
Perioperative intravenous antibiotic prophylaxis
Adherence to regimen: ‐ |
Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
|
Notes |
Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: Quote:"This study was approved by the Ethics Committee of Tokai University" Informed consent: Quote: "Patients provided written informed consent" Clinical trials registration: Quote:"The trial registration number is University Hospital Medical Information Network (UMIN) Clinical Trials Registry 000003435" Sample size calculation: Quote: "Assuming an SSI rate of 9% each in the oral antibiotics group and the probiotics group and an SSI rate of 30% in the control group, we calculated the number needed to treat that would have 90% power to detect differences between the oral antibiotics group and the control group and between the probiotics group and the control group by the Fisher exact test at an overall level of significance of 0.05 (two‐sided). We then calculated the number needed to treat per group at a two‐sided significance level of 0.0253 for each comparison, adjusting for multiplicity associated with multiple tests by the Dunn‐Sidak method. The number needed to treat was thus calculated to be 92 per group. To allow for possible dropouts, a sample size of 300 patients (100 patients per group) was established for this study." |