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

Zmora 2003.

Study characteristics
Methods Study design: Parallel‐group randomised trials
Duration of trial: July 1997 to July 2000
Duration of follow‐up: 30 days
Country of origin: Israel
Participants Baseline characteristics
Number randomised: 415 participants
Number analysed: 380 participants
Intervention: MBP+oAB
  • Number of participants [n]: 187

  • Age [years; mean (range)]: 68 (22–89)

  • Gender [male/female; n]: 103/84


Control: oAB
  • Number of participants [n]: 193

  • Age [years, mean (range)]: 68 (23–92)

  • Gender [male/female; n]: 94/99


Inclusion criteria 
Quote: "Patients undergoing elective colon and rectal surgery with primary anastomosis"
Exclusion criteria
Quote: "Patients with tumors smaller than 2 cm were excluded from the study, as palpation of small tumors may be difficult in an unprepared bowel, and these patients may require intraoperative colonoscopy to identify these lesions. Patients who required a diverting stoma proximal to the anastomosis and those who were found to have an abdominal abscess at the time of surgery were also excluded from the data analysis."
Baseline imbalances
Quote:"Demographic characteristics, indications for surgery, and type of surgery did not significantly differ between the two groups."
Interventions Comparison
  • Intervention: MBP+oAB

  • Control: oAB


MBP
  • Agent(s): polyethylene glycol (additional enema before rectal surgery)

  • Dose per administration: one gallon

  • Time(s) of intake: 12 to 16 hours before surgery (on the day of surgery)

  • Route: oral,rectal

  • Concomitant medications: ‐


oAB
  • Agent(s): neomycin and erythromycin

  • Dose per administration: ‐

  • Time(s) of intake: "three doses before surgery"

  • Route: oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): Quote: "Perioperative broad‐spectrum intravenous antibiotics"

  • Dose per administration: ‐

  • Time(s) of intake:Quote:  "perioperative; continued for at least 24 hours postoperatively. Surgeons were allowed to continue the prophylactic intravenous antibiotics for more then 1 day, and the length of prophylactic treatment was recorded."


Adherence to regimen: 193 Patient excluded since they did not have MBP
Outcomes Outcomes sought in review and reported in trial
  • SSI

  • Anastomotic leakage

  • Incidence of postoperative ileus


Outcomes sought but not reported in trial
  • Mortality

  • 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
  • Non‐surgical Infections

  • GI bleeding

  • Bowel cleansing assessment

Notes Source of funding:
Conflicts of interest:
Ethics approval:  Quote:"The study was approved by the Institutional Review Board (Helsinki committee)"
Informed consent:  Quote:Patients gave their informed consent before randomization."
Clinical trials registration:
Sample size calculation:

D/C: Clavien‐Dindo classification; IV: intravenous; MBP: mechanical bowel preparation; MBP+oAB: combined mechanical and oral antibiotic bowel preparation; nMB: no bowel preparation; oAB: oral antibiotics as bowel preparation; PEG: polyethylene glycol; SD: standard deviation;  SSI: surgical site infection