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

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
  • Number of participants [n]: 289

  • Age [years; mean (range)]: 67 (60.5 ‐ 75.0)

  • Gender [male/female; n]: 153/136


Control: MBP
  • Number of participants [n]: 290

  • Age [years, mean (range)]: 67.5 (60.0 ‐ 75.0)

  • Gender [male/female; n]: 175/115


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
  • Intervention: MBP+oAB

  • Control: MBP


MBP
  • Agent(s): sodium picosulfate and magnesium citrate and water

  • Dose per administration: 75 mg and 34 g and 180 mL

  • Time(s) of intake: The day before the surgery

  • Route: oral

  • Concomitant medications: ‐


oAB
  • Agent(s): kanamycin and metronidazole

  • Dose per administration: 1 g and 750 mg

  • Time(s) of intake: at 13 hours and 9 hours before the surgery

  • Route: oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): cefmetazole

  • Dose per administration: 1 g

  • Time(s) of intake: 30 min before surgery, additional dose every 3 hours during surgery


Adherence to regimen: ‐
Outcomes Outcomes sought in review and reported in trial
  • SSI (superficial, deep and organ/space)

  • Anastomotic leakage

  • Incidence of postoperative ileus


Outcomes sought but not reported in trial
  • Mortality

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

  • Length of hospital stay

  • Side effects of Intervention(s)


Outcomes reported in trial but not used in review
  • Other infectious complication

  • Postoperative noninfectious complication

  • Bowel obstruction

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."