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

Lewis 2002.

Study characteristics
Methods Study design: Parallel‐group randomised trials
Duration of trial: 1992 ‐ 1995
Duration of follow‐up: Quote: "The patients were followed up by the infection control nurse on postoperative days 3, 5 to 7, 10 to 14, and at 1 month for diagnosis of surgical site infection, using the modified CDC criteria."
Country of origin: Canada
Participants Baseline characteristics
Number randomised: 215 participants
Number analysed: 213 participants
Intervention: MBP+oAB
  • Number of participants [n]: 108

  • Age [years; mean (SD)]: 68.8 (13.5)

  • Gender [male/female; n]: 53/56


Control: MBP
  • Number of participants [n]: 105

  • Age [years, mean (SD)]: 71.4 (12.9)

  • Gender [male/female; n]: 43/63


Inclusion criteria 
Quote: "All patients who underwent elective surgery of the colon at the Queen Elizabeth Hospital in Montreal were eligible to enter the study"
Exclusion criteria
Quote: "Patients who were allergic to the study antibiotics or who had received antibiotics within the 2 weeks before operation, pregnant patients and those who refused informed consent were excluded."
Baseline imbalances
Quote: "The treatment groups were evenly matched with respect to age, gender, body mass index and preoperative serum albumin level and blood lymphocyte count. There were no significant differences between the groups with respect to the preoperative final diagnoses and operations performed."
Interventions Comparison
  • Intervention: MBP+oAB

  • Control: MBP


MBP
  • Agent(s): sodium phosphate (and saline enemas)

  • Dose per administration: ‐

  • Time(s) of intake: Quote: "on the day before surgery until the rectal effluent was clear. If not, saline enemas were given at 1800 on the day before operation until they were clear"

  • Route: oral/rectal

  • Concomitant medications: ‐


oAB
  • Agent(s): neomycin and metronidazole

  • Dose per administration: 2 g each

  • Time(s) of intake: at 19.00, and 23.00 hours on the day before surgery

  • Route: oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): amikacin and metronidazole

  • Dose per administration: 1 g each

  • Time(s) of intake: Quote: "On the way to the operating room"


Adherence to regimen: ‐
Outcomes Outcomes sought in review and reported in trial
  • SSI

  • Anastomotic leakage


Outcomes sought but not reported in trial
  • Mortality

  • Incidence of postoperative ileus

  • 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
  • Organisms found in wound

Notes Source of funding:
Conflicts of interest:
Ethics approval:
Informed consent: Quote: "All patients gave informed consent to participate in the study"
Clinical trials registration:
Sample size calculation:Quote:  "The sample size was calculated assuming an infection rate at the surgical site of 10% to 15%, and a treatment difference of 10% (α risk 0.05, β risk 0.20)"