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

Lau 1988.

Study characteristics
Methods Study design: Parallel‐group randomised trials
Duration of trial: May 1981 to June 1987
Duration of follow‐up: 3 months
Country of origin: Hong Kong
Participants Baseline characteristics
Number randomised: 140 participants
Number analysed: 132 participants
Intervention: MBP+oAB
  • Number of participants [n]: 65

  • Age [years; mean (SD)]: 62.3 (15.7)

  • Gender [male/female; n]: 37/28


Control: MBP
  • Number of participants [n]: 67

  • Age [years, mean (SD)]: 63.5 (14.9)

  • Gender [male/female; n]: 137/105


Inclusion criteria 
"Elective colorectal surgery for carcinoma"
Exclusion criteria
Quote: "Inflammatory bowel disease, an existing colostomy, an active infection, a history of sensitivity to any of the antibiotics used, a history of renal insufficiency or eighth nerve dysfunction, an obstructing colonic lesion, or a history of receiving antibiotics within the 2 weeks before operation."
Baseline imbalances
Quote:"The randomised groups were well matched with respect to patient characteristics and surgical procedures"
Interventions Comparison
  • Intervention: MBP+oAB

  • Control: MBP


MBP
  • Agent(s): bisacodyl, magnesium sulphate and saline enema

  • Dose per administration: ‐

  • Time(s) of intake: 3‐day preparation

  • Route: oral/rectal

  • Concomitant medications: ‐


oAB
  • Agent(s): neomycin and erythromycin

  • Dose per administration: 1000 mg each

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

  • Route:oral

  • Concomitant medications: ‐


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

  • Dose per administration: 500 mg/kg/KG and 2 mg/kg/KG

  • Time(s) of intake: over half an hour just before surgery


Adherence to regimen: Quote:"3 patients were excluded due to violation of the study protocol"
Outcomes Outcomes sought in review and reported in trial
  • SSI

  • Anastomotic leakage

  • 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)

  • Incidence of postoperative ileus

  • Side effects of Intervention(s)


Outcomes reported in trial but not used in review
  • Fever of unknown origin

Notes Source of funding:
Conflicts of interest:
Ethics approval: Quote: "The study was approved by the ethics boards of the participating centers"
Informed consent: Quote: "After informed consent was obtained, patients were stratified into three categories"
Clinical trials registration:
Sample size calculation: Quote: "The initial study was projected to require 200 patients to show a statistical difference. We analysed our results statistically after inclusion of the first 202 patients"