Hata 2016.
Study characteristics | |
Methods |
Study design: Parallel‐group randomised trials Duration of trial: November 2007 to December 2012 Duration of follow‐up: 30 days Country of origin: Japan |
Participants |
Baseline characteristics
Number randomised: 584 participants
Number analysed: 579 participants
Intervention: MBP+oAB
Control: MBP
Inclusion criteria Quote:"Patients undergoing elective laparoscopic colorectal surgery for colorectal cancer or adenoma; aged 20 years or older, having good oral intake, and having adequate organ function." Exclusion criteria Quote:"Bowel obstruction, preoperative infections, antibiotic use within 2 weeks before the surgery; preoperative steroid use, neoadjuvant radiation and/or chemo therapy, uncontrolled diabetes mellitus, pregnant or lactating woman, and severe allergy" Baseline imbalances Quote:"The 2 groups were well balanced at the baseline." |
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: Quote: "This study was funded by JMTO, a general incorporated association established in 1999 to support clinical trials, especially multicenter or multinational randomised controlled trials, for the diagnosis, treatment, and prevention of the diseases. The sponsor had no involvement in the design or conduct of the study." Conflicts of interest: Quote: "The authors have no conflicts of interest to declare." Ethics approval: "This study was approved by the JMTO Ethics Committee in February 2007 and also by the institutional review boards of all of the participating hospitals." Informed consent: Quote:"All patients provided written informed consent before randomization." Clinical trials registration: NCT00508690 Sample size calculation: Quote:"It was planned to enroll 566 patients during the trial design. This sample size would provide an 80% power with a 2‐sided significance level of 0.05 to demonstrate the superiority of the Oral‐IV group in the reduction of SSI rate." |