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
Control: nBP
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
MBP
oAB
Perioperative intravenous antibiotic prophylaxis
Adherence to regimen: ‐ |
| 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: 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" |