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

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
  • Number of participants [n]: 99

  • Age [years; mean (SD)]: 67 (11)

  • Gender [male/female; n]: 56/43


Control: nBP
  • Number of participants [n]: 95

  • Age [years, mean (SD)]: 66 (12)

  • Gender [male/female; n]: 51/44


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
  • Intervention: MBP+oAB (Group B)

  • Control: MBP (Group C)

  • Group A (MBP + probiotics) was not included in the meta‐analysis


MBP
  • Agent(s): sodium picosulfate (1) and polyethylene glycol–electrolyte sodium (2)

  • Dose per administration: 10 mL (1) and 2000 mL (2)

  • Time(s) of intake: 2 days before surgery (1) and in the morning of the day before the operation (2)

  • Route: oral

  • Concomitant medications: ‐


oAB
  • Agent(s): kanamycin sulfate and metronidazole

  • Dose per administration: 0.5 g each

  • Time(s) of intake: at 1:00 PM, 2:00 PM, and 11:00 PM the day before the procedure

  • Route: oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): fomoxef

  • Dose per administration: 1 g

  • Time(s) of intake: Quote:"1 hour before making an incision. When the operation time exceeded 3 hours, another 1 g dose of flomoxef was administered."


Adherence to regimen: ‐
Outcomes Outcomes sought in review and reported in trial
  • SSI (incisional and organ/speace)

  • Anastomotic leakage


Outcomes sought but not reported in trial
  • 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
  • Analysis of faecal flora

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."