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. 2023 Feb 7;2023(2):CD014909. doi: 10.1002/14651858.CD014909.pub2

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
  • Number of participants [n]: 91

  • Age: ‐

  • Gender [male/female; n]: 69/22


Control: nBP
  • Number of participants [n]: 94

  • Age: ‐

  • Gender [male/female; n]: 77/17


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
  • Intervention: MBP+oAB

  • Control: MBP


MBP
  • Agent(s): 0.75 % sodium picosulfate hydrate magnesium citrate solution

  • Dose per administration: 20 mL

  • Time(s) of intake at 11:00 AM on the day before surgery

  • Route:oral

  • Concomitant medications: ‐


oAB
  • Agent(s): kanamycin and metronidazole

  • Dose per administration: 500 mg each

  • Time(s) of intake: at 2:00 PM, 3:00 PM, and 9:00 PM on the day before surgery

  • Route:oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): fomoxef sodium

  • Dose per administration: ‐

  • Time(s) of intake: 30 minutes before the surgery and repeatedly for every 3 hours during the surgery


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
  • SSI (incisional and organ/speace)


Outcomes sought but not reported in trial
  • Anastomotic leakage

  • Mortality

  • Length of hospital stay

  • Postoperative complications (mild D/C I + II or severe D/C III+IV)

  • Incidence of postoperative ileus

  • Side effects of Intervention(s)


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."