Papp 2021.

Study characteristics
Methods	Study design: Parallel‐group randomised trials Duration of trial: November 2016 to June 2018 Duration of follow‐up: 30 days Country of origin: Hungary
Participants	Baseline characteristics Number randomised: 600 participants Number analysed: 529 participants Intervention: MBP+oAB Number of participants [n]: 253 Age [years; mean (SD)]: 66.1 (12.1) Gender [male/female; n]: 152/101 Control: MBP Number of participants [n]: 276 Age [years, mean (SD)]: 66.5 (12.3) Gender [male/female; n]: 130/146 Inclusion criteria  Quote: "All indications for colorectal anastomosis were considered eligible, including Hartmann’s reversal, with the exception of loop colostomy closure." Exclusion criteria Quote: "Patients requiring colostomy alone or having to undergo surgery for hemorrhagic rectocolitis, as well as patients who had received antibiotics for seven days prior to surgery, were excluded from the study." Baseline imbalances none
Interventions	Comparison Intervention: MBP+oAB Control: MBP MBP Agent(s): castor oil and paraffin and enema(s) Dose per administration: 40 mL and 20 mL Time(s) of intake: on the day before surgery; enema was given in the evening before surgery and again on the morning of surgery Route: oral/rectal Concomitant medications: ‐ oAB Agent(s): metronidazole neomycin sulphate Dose per administration: 500 mg and 1000 mg Time(s) of intake: at 13.00, 15.00, and 19.00 hours on the day before surgery Route: oral Concomitant medications: ‐ Perioperative intravenous antibiotic prophylaxis Agent(s): ceftriaxone and metronidazole Dose per administration: 2 g and 500 mg Time(s) of intake:Quote:  "Within 60 min of the incision. This was repeated if operating time exceeded 4 h and/or blood loss exceeded 1500 ml" Adherence to regimen: ‐
Outcomes	Outcomes sought in review and reported in trial SSI Anastomotic leakage Mortality Postoperative complications (mild D/C I + II or severe D/C III+IV) Incidence of postoperative ileus Outcomes sought but not reported in trial Length of hospital stay Side effects of Intervention(s) Outcomes reported in trial but not used in review Readmission
Notes	Source of funding: Quote: "The SOAP study non‐commercial" Conflicts of interest:Quote:  "The authors declare no conflict of interest" Ethics approval: Quote: "Ethical approval was granted by both the Hungarian National Institute of Pharmacy and Nutrition and the Hungarian Medical Research Council." Informed consent: All patients gave informed consent Clinical trials registration: EudraCT 2015‐005614‐30 Sample size calculation: Quote: "The study power calculation was based on the international literature, with an estimated 11 per cent incidence of SSI in the OABP– group and 5 per cent in the OABPþ group. Postoperative ileus was estimated to occur in 6 percent of patients in the OABP– group and 3 percent in the OABP+ group. Using d ¼ 3 and an adjusted study power of 80 percent with a 95 percent confidence interval, it was calculated that 282 patients were required for the SSI primary endpoint and 374 for the postoperative ileus endpoint. This was rounded up to 400 patients and, after adjusting for a possible 12.5 percent loss, the final sample size was estimated to be 450 patients."