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

Lazorthes 1982.

Study characteristics
Methods Study design: Parallel‐group randomised trials
Duration of trial: January 1979 to March 1980
Duration of follow‐up: 2 months
Country of origin: France
Participants Baseline characteristics
Number randomised: 90 participants
Number analysed: 90 participants
Number eligible and included in this review: 60
Only a subset of the study patients was included in the meta‐analysis. Patients in study group O did not receive perioperative intravenous antibiotic prophylaxis and were therefore excluded from the meta‐analysis.
Intervention: MBP+oAB
  • Number of participants [n]: 30

  • Age [years; mean (SD)]: 64.8 (11.94)

  • Gender [male/female; n]: 20/10


Control: MBP
  • Number of participants [n]: 30

  • Age [years, mean (SD)]: 65.4 (10.21)

  • Gender [male/female; n]: 14/16


Inclusion criteria 
Elective colorectal surgery
Exclusion criteria
Quote:"Patients requiring colostomy alone* or having to undergo surgery for hemorrhagic rectocolitis, as well as patients who had received antibiotics for seven days prior to surgery, were excluded from the study."
Baseline imbalances
None
Interventions Comparison
  • Intervention: MBP+oAB + antibiotic administered intramuscularly (Group O + S´)

  • Control: MBP (Group S)


MBP
  • Agent(s): magnesium sulfate and procedures such as enemas and low‐residue diet

  • Dose per administration: ‐

  • Time(s) of intake: over three days preoperatively

  • Route: oral/rectal

  • Concomitant medications: ‐


oAB
  • Agent(s): kanamycin and metronidazole

  • Dose per administration: 1000 mg and 250 mg

  • Time(s) of intake: Quote:"During the three days prior to surgery in four equally divided doses"

  • Route: oral

  • Concomitant medications: 2 mg/kg/KG gentamicin i.m. at the time of premedication


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): cephradine

  • Dose per administration: 2 g

  • Time(s) of intake: During induction of surgery


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

  • Length of hospital stay


Outcomes sought but not reported in trial
  • SSI

  • Anastomotic leakage

  • 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
  • Wound abscesses

  • Septicaemia

  • Fistula

  • Abdominal abscesses

  • Septic deaths

Notes Source of funding:
Conflicts of interest:
Ethics approval:
Informed consent:
Clinical trials registration:
Sample size calculation: