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
Control: oAB
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
MBP
oAB
Perioperative intravenous antibiotic prophylaxis
Adherence to regimen: 193 Patient excluded since they did not have MBP |
Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
|
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