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

Ram 2005.

Study characteristics
Methods Study design: Parallel‐group randomised trials
Duration of trial: April 1999 to March 2002
Duration of follow‐up: Quote: "Complications were registered daily after surgery, and patients were re‐examined at the outpatient clinic 1, 3, and 6 weeks following surgery"
Country of origin: Israel
Participants Baseline characteristics
Number randomised: 329 participants
Number analysed: 329 participants
Intervention: MBP+oAB
  • Number of participants [n]: 164

  • Age [years; mean (SD)]: 68.17 (11.5)

  • Gender [male/female; n]: 99/65


Control: oAB
  • Number of participants [n]: 165

  • Age [years, mean (SD)]: 68.11 (9.5)

  • Gender [male/female; n]: 102/63


Inclusion criteria 
Quote: "Elective colorectal procedures for nonobstructive large bowel pathologic features"
Exclusion criteria
Quote: "Patients in both groups were excluded if they had taken antibiotics for the last 10 days before surgery or if there was evidence of infection. Patients undergoing emergency operations were not included. Patients randomised to group 2 were excluded if they had bowel preparation for colonoscopy within 6 days prior to surgery. Patients undergoing proctectomy with low rectal anastomosis or surgery for polypoid lesion were also excluded."
Baseline imbalances
none
Interventions Comparison
  • Intervention: MBP+oAB

  • Control: oAB


MBP
  • Agent(s): soffodex (monobasic sodium phosphate and dibasic sodium phosphate)

  • Dose per administration: 2.4/0.9 g

  • Time(s) of intake: On the day before surgery

  • Route: oral

  • Concomitant medications: ‐


oAB
  • Agent(s): ‐

  • Dose per administration: ‐

  • Time(s) of intake: ‐

  • Route: oral

  • Concomitant medications: ‐


Perioperative intravenous antibiotic prophylaxis
  • Agent(s): ceftriaxone and metronidazole

  • Dose per administration: 1 g and 500 mg

  • Time(s) of intake: 1 hour before induction. The same antibiotic prophylaxis was continued for 48 hours following the operation


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

  • Anastomotic leakage

  • Mortality

  • Incidence of postoperative ileus


Outcomes sought but not reported in trial
  • 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:  Quote:"The study was approved by the hospital ethics committee."
Informed consent: All patients gave informed consent
Clinical trials registration:
Sample size calculation: