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

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
  • Number of participants [n]: 223

  • Age [years; mean (SD)]: 62.7 (12.6)

  • Gender [male/female; n]: 122/101


Control: MBP
  • Number of participants [n]: 216

  • Age [years, mean (SD)]: 60.1 (11.8)

  • Gender [male/female; n]: 122/94


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
  • Intervention: MBP+oAB

  • Control: MBP


MBP
  • Agent(s): magnesium citrate (1) and sodium picosulfate (2)

  • Dose per administration: ‐

  • Time(s) of intake: at 08.00 hours (1) and at 11.00 hours (2) on the day before surgery

  • Route: oral

  • Concomitant medications: ‐


oAB
  • Agent(s): metronidazole and kanamycin

  • Dose per administration: 750 mg and 1000 mg

  • Time(s) of intake: at 15.00 and 21.00 hours on the day before the surgery

  • Route: oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): cefmetazole

  • Dose per administration: 1000 mg

  • Time(s) of intake: Quote: ""At least 30 min before skin incision, then every 3 h during surgery until skin closure. After completion of surgery, two additional doses of intravenous prophylaxis were given within 24 h."


Adherence to regimen:Quote: " "All patients except for two received the planned antimicrobial doses."
Outcomes Outcomes sought in review and reported in trial
  • SSI (superficional, deep and organ/space)

  • Anastomotic leakage

  • Incidence of postoperative ileus

  • Length of hospital stay


Outcomes sought but not reported in trial
  • Mortality

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

  • Side effects of Intervention(s)


Outcomes reported in trial but not used in review
  • Intra‐abdominal abscess

  • Urinary tract disorder

  • Anastomotic haemorrhage

  • Readmission within 30 days

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."