Uchino 2019.
Study characteristics | |
Methods |
Study design: Parallel‐group randomised trials Duration of trial: March 2014 to February 2017 Duration of follow‐up: Quote: "The wounds were inspected daily by a nurse, once a week by the surveillance member, and an attending physician during the hospital stay, and at the 4‐week and 3‐month postoperative follow‐up visits." Country of origin: Japan |
Participants |
Baseline characteristics
Number randomised: 325 participants
Number analysed: 321 participants
Number eligible and included in this review: 185 Only a subset of the study patients was included in the meta‐analysis. All patients who underwent colon or rectal surgery with intestinal anastomosis were eligible. Intervention: MBP+oAB
Control: nBP
Inclusion criteria "Patients undergoing surgery for Crohn disease." Exclusion criteria Quote: "Patients with emergent surgery, allergy to antibiotics, and antibiotic use within the 2 weeks before surgery were excluded. Moreover, patients treated with a long‐tube insertion due to bowel obstruction or surgery for an anal lesion alone were also excluded." Baseline imbalances None |
Interventions |
Comparison
MBP
oAB
Perioperative intravenous antibiotic prophylaxis
Adherence to regimen Quote: "Protocol violations were detected in 2 patients in group A and 3 patients in group B, and the remaining 320 patients were included in the PP analysis." |
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: Quote: "The authors report no conflicts of interest." Ethics approval: Quote:"All study protocols were approved by the Institutional Review Board of the Hyogo College of Medicine (No. 1679)." Informed consent: Quote: "Informed consent was required from all participants" Clinical trials registration:Quote: "The study protocols were registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN‐CTR 000013369)." Sample size calculation: Quote: "It was previously reported that the incidence of SSI in CD surgery without oral antibiotic prophylaxis was approximately 25%. When the power was set to 80%, it was assumed that 149 patients would be required in each group to detect a difference between an SSI rate of 12.5% and 25% (favoring oral antibiotic prophylaxis) with a probability of a type 1 error <0.05. To allow for the potential loss of evaluable patients, a total sample size of 160 patients in each arm was chosen." |