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

Takesue 2000.

Study characteristics
Methods Study design: Parallel‐group randomised trials
Duration of trial: April 1997 to November 1997
Duration of follow‐up: Quote: "until discharged from the hospital"
Country of origin: Japan
Participants Baseline characteristics
Number randomised: 100 participants
Number analysed: 83 participants
Intervention: MBP+oAB
  • Number of participants [n]: 38

  • Age [years; median (range)]: 65 (29‐85)

  • Gender [male/female; n]: 25/13


Control: MBP
  • Number of participants [n]: 45

  • Age [years, median (range)]: 68 (34‐81)

  • Gender [male/female; n]: 29/16


Inclusion criteria 
Quote: "Elective colorectal surgery"
Exclusion criteria
Quote:"MBP not possible; antibiotics within least 15 days; emergency colonic obstruction"
Baseline imbalances
None
Interventions Comparison
  • Intervention: MBP+oAB

  • Control: MBP


MBP
  • Agent(s): PEG lavage

  • Dose per administration: ‐

  • Time(s) of intake: 10 AM to 2 PM on the day before surgery

  • Route: oral

  • Concomitant medications: ‐


oAB
  • Agent(s): kanamycin and metronidazole

  • Dose per administration: 500 mg each

  • Time(s) of intake: at 2 PM, 3 PM and 11 PM (when surgery was scheduled for 9 AM)

  • Route: oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): cefmetazole

  • Dose per administration: 1 g

  • Time(s) of intake:Quote:  "after induction of anesthesia; and three times daylie for 3 consecutive days after the operation"


Adherence to regimen: 17 excluded after randomisation (12 in MBP+oAB group an 5 in oAB group)
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
  • Anastomotic bleeding

  • Abdominal/pelvic collection

  • Urinary tract infection

  • Pulmonary complications

  • Thrombophlebitis

  • Relaparotomy

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