Ikeda 2016.
Study characteristics | |
Methods |
Study design: Parallel‐group randomised trials Duration of trial: June 2013 to April 2014 Duration of follow‐up: 30 days Country of origin: Japan |
Participants |
Baseline characteristics
Number randomised: 515 participants
Number analysed: 511 participants
Number eligible and in this review included participants: 439 Only study patients who underwent preoperative mechanical bowel preparation were included in the meta‐analysis. Intervention: MBP+oAB
Control: MBP
Inclusion criteria Quote: ""All consecutive patients with colorectal cancer undergoing elective laparoscopic colorectal resection" Exclusion criteria Quote: ""Age less than 20 years; patients with bowel obstruction and who could not tolerate liquid intake; pregnancy; history of allergy to the drugs in the protocol; administration of antibiotics in the 2 weeks before surgery; severe dysfunction of liver, kidney, heart or lung; and synchronous resection of other major organs such as the stomach, liver or uterus" Baseline imbalances Quote: ""The patient characteristics of the two groups were well balanced at baseline" |
Interventions |
Comparison
MBP
oAB
Perioperative intravenous antibiotic prophylaxis
Adherence to regimen:Quote: " "All patients except for two received the planned antimicrobial doses." |
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
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Notes |
Source of funding: ‐ Conflicts of interest: None Ethics approval: Quote:" "The study was conducted with the approval of the ethics committee of the Cancer InstituteHospital of the Japanese Foundation for Cancer Research, Tokyo, Japan" Informed consent: Written informed consent was obtained from all participants Clinical trials registration: Quote: ""This trial is registered with the UMIN Clinical Trials Registry (UMIN000019339)." Sample size calculation: Quote: ""Assuming a one‐sided α of 0⋅05, a power of 80 per cent and a 5 per cent incidence of overall SSI in both groups, 235 patients per group were needed (Dunnett–Gent test)7. Assuming an 8 per cent drop‐out rate, the planned required sample size was 253 patients." |