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

Koskenvuo 2019.

Study characteristics
Methods Study design: Parallel‐group randomised trials
Duration of trial: March 2016 to August 2018
Duration of follow‐up: Quote: ""During the hospital stay and at 1‐month clinical follow‐up visit at the outpatient clinic"
Country of origin: Finland
Participants Baseline characteristics
Number randomised: 417 participants
Number analysed: 396 participants

Intervention: MBP+oAB
  • Number of participants [n]: 196

  • Age [years; mean (range)]: 69.9 (61.1‐75.2)

  • Gender [male/female; n]: 105/91


Control: nBP
  • Number of participants [n]: 200

  • Age [years, mean (range)]: 70.3 (61‐76)

  • Gender [male/female; n]: 96/104


Inclusion criteria 
Quote: ""Patients scheduled for colon resection in participating centres. Both benign and malignant indications were eligible, as were both laparoscopic and open procedures."
Exclusion criteria
Quote: ""Need for emergency surgery; bowel obstruction; colonoscopy planned to be undertaken during surgery; other indications for mechanical preparation or contraindications; allergy to drugs used in the trial (polyethylene glycol, neomycin, metronidazole); and age younger than 18 years or older than 95 years."
Baseline imbalances
Quote: ""Patient baseline characteristics were similar between the two groups"
Interventions Comparison
  • Intervention: MBP+oAB

  • Control: nBP


MBP
  • Agent(s): polyethylene glycol

  • Dose per administration: 2000 mL

  • Time(s) of intake: before 6 PM on day before surgery

  • Route: oral

  • Concomitant medications: ‐


oAB
  • Agent(s): neomycin and metronidazole

  • Dose per administration: 2 g each

  • Time(s) of intake: Neomycin at 7 PM and metronidazole at 11 PM

  • Route:oral

  • Concomitant medications: ‐


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

  • Dose per administration: 1500 mg and 500 mg

  • Time(s) of intake:Quote: ""At the start of anaesthesia before skin incision. The prophylactic intravenous antibiotics were re‐administered if the surgery lasted longer than 3 h from the first antibiotic dose, or if blood loss exceeded 1,5 L"


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

  • Anastomotic leakage

  • Mortality

  • Length of hospital stay

  • Side effects of oAB


Outcomes sought but not reported in trial
  • Postoperative complications (mild D/C I + II or severe D/C III+IV)

  • Incidence of postoperative ileus

  • Side effects of MBP


Outcomes reported in trial but not used in review
  • Comprehensive Complication Index

  • Prevalence of adjuvant therapy

  • 5‐year overall survival

Notes Source of funding: Quote: " "Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, and Helsinki University Hospital research funds"
Conflicts of interest: "VS reports grants from Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, and Helsinki University Hospital research funds, during the conduct of the study; grants from Finnish Surgical Society, Finska Läkaresällskapet, and Finnish Gastroenterological Society; personal fees from City of Vantaa, Finnish Gastroenterological Society, Novartis, and University of Helsinki; and non‐financial support from Astellas, outside of the submitted work. TS reports personal fees from Johnson & Johnson’s laparoscopic colorectal surgery advisory board, outside of the submitted work. All other authors declare no competing interests"
Ethics approval: Quote: ""The research plan was approved by the Finnish National Committee on Medical Research Ethics and Finnish Medicines Agency. The research plan was further approved by the local ethics committee of Helsinki University Hospital and by each participating centre’s institutional review board (Helsinki University Hospital, Oulu University Hospital, Central Finland Central Hospital, and Seinäjoki Central Hospital)"
Informed consent: Patients provided written informed consent
Clinical trials registration: ClinicalTrials.gov (NCT02652637) and EudraCT (2015–004559–38)
Sample size calculation: Quote: " "With a power of 80% and significance at 5%, 396 patients would be needed to show this difference. The sample size was adjusted for a possible 5% loss, yielding a final sample size of 415 patients"