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

Anjum 2017.

Study characteristics
Methods Study design: parallel‐group randomised trials
Duration of trial: July 2014 to January 2016
Duration of follow‐up: "All outcomes were evaluated daily during the hospital stay, and postoperative follow‐up was conducted on postoperative days 30 and 90"
Country of origin: China
Participants Baseline characteristics
Number randomised: 190 participants
Number analysed: 184 participants

Intervention: MBP+oAB
  • Number of participants [n]: 91

  • Age [years; mean (SD)]: 46.3 (14.4)

  • Gender [male/female; n]: 61/34


Control: MBP
  • Number of participants [n]: 93

  • Age [years, mean (SD)]: 45.2 (15.6)

  • Gender [male/female; n]: 59/36


Inclusion criteria 
18 years of age or older and scheduled for elective colorectal surgery
Exclusion criteria
Patients were excluded if they had any preoperative infection or bowel obstruction, if they were undergoing emergency laparotomy, if they used antibiotics 2 weeks preoperatively, or were being treated with steroids or immunosuppressants preoperatively
Baseline imbalances
None
Interventions Comparison
  • Intervention: MBP+oAB

  • Control: MBP


 
MBP
  • Agent(s): sodium phosphate

  • Dose per administration: 133 mL

  • Time(s) of intake: twice a day on the day before the surgery

  • Route: oral

  • Concomitant medications: ‐


 
oAB
  • Agent(s): metronidazole and levofloxacin

  • Dose per administration: 400 mg and 200 mg

  • Time(s) of intake: at 3:00 PM, 7:00 PM, and 11:00 PM on the day before the surgery

  • Route: poral.

  • Concomitant medications: ‐


 
Perioperative intravenous antibiotic prophylaxis
  • Agent(s): second‐generation cephalosporin and metronidazole

  • Dose per administration: ‐

  • Time(s) of intake: 30 to 60 minutes before the surgery and repeated every 3 hours during surgery; the antibiotics were continued for 24 hours following surgery.


 
Adherence to regimen: Two patients were excluded due protocol violations
Outcomes Outcomes sought in review and reported in trial
  • SSI (incisional, deep and organ/space)

  • Incidence of postoperative ileus


Outcomes sought but not reported in trial
  • Anastomotic leakage

  • Mortality

  • Length of hospital stay

  • Postoperative complications (mild D/C I + II or severe D/C III + IV)

  • Side effects of Intervention(s)


Outcomes reported in trial but not used in review
  • Extra‐abdominal complications

  • Readmission rates

Notes Source of funding: This work was supported by the National Natural Science Foundation of China (grant number 81270478)
Conflicts of interest:
Ethics approval: The study was approved by the ethical committee of the Jinling Hospital
Informed consent: All participants gave their informed consent before randomisation
Clinical trials registration:
Sample size calculation: "To reach a power of 80%, it was estimated that 90 patients would be required in each group to detect the difference of SSI between 18% and 6% with a type I error of 0.05. A total sample size of 95 patients was established for each arm."