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Table 3 RCTs investigating the role of OABs in elective colorectal surgery

From: The gut microbiota and colorectal surgery outcomes: facts or hype? A narrative review

Author (year) Trial Name/Type/Country Status Analyzed sample size and included population Intervention Outcome Results
Abis (2019) [10] SELECT
NCT01740947
Phase III
Multicentric
Netherlands
Stopped at interim analysis (superiority not attainable) 455 patients
(762 planned)
All colorectal resections
OABs (colistin, tobramycin and amphotericin B) vs no preparation
MBP + OABs vs no preparation for left-sided and rectal resections
AL (primary outcome)
Infectious complications
(secondary outcome)
NS difference in AL (6.1 vs 9.7%, OR 0.61 CI 95%, 0.30–1.22)
Reduced infectious complications (14.9 vs 26.9%, OR 0.47, CI 95% 0.29–0.76 at the multivariable analysis)
Koskenvuo (2019) [11] MOBILE
NCT02652637
Phase III
Multicentric
Finland
Completed 396 patients
All colorectal resections
MBP + OABs (neomycin and metronidazole) versus no bowel preparation SSIs (primary outcome)
AL, reoperation rate (secondary outcomes)
NS difference in SSIs (7 vs 11%, OR 1·65, 95% CI 0·80–3·40; p = 0·17), AL (4 vs 4%), reoperation rate (8 vs 7%)
Schardey (2020) [12] -
-
Phase III
Monocentric
Germany
Stopped at interim analysis
(ethical reasons)
80 patients (280 planned)
Only rectal resections
MPB + OABs (polymyxin B, tobramycin, vancomycin, and amphotericin B) versus MBP + placebo (+ amphotericin B) AL (primary outcome)
Infectious complications (secondary outcome)
Reduced leak in the MPB + OABs group
(5% versus 20%, p = 0.0425)
NS difference for infectious complications
Basany(2020) [13] ORALEV
NCT02505581
Phase III multicentric
Spain
Completed 536 patients
Only colic resections (no rectal resections)
OABs (ciprofloxacin + metronidazole) vs no OABs SSIs Reduced SSIs in the OAB group (5% vs 11%, p = 0.013). Organ/space SSIs similar (1.9% vs 2.6%, p = NS)
  ORALEV2
NCT04161599
Phase III multicentric
International
Recruiting 686 patients planned MBP + OABs vs. OABs alone SSIs Ongoing