Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery.

Summary

Elective colon surgery is considered a clean-contaminated procedure, with a Surgical Site Infection (SSI) rate not inferior to 10%. For many years the role of Mechanical Bowel Preparation (MBP) has been universally recognized as an effective measure to reduce colonic bacterial load and consequently SSI rate, mostly in European Countries. However, in the early 1970s has been demonstrated a further SSI risk reduction in colon surgery if oral non-absorbable antibiotics were added to MBP and for the next 30 years this became the standard of care prior to elective colon surgery, especially in the US. Nowadays, Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or mortality, and as such it should not be prescribed routinely. Conversely, recent evidence has suggested that there may be a role for combined MBP and oral antibiotics, or oral antibiotics alone in the prevention of surgical site infection (SSI). The aim of this trial is to evaluate the efficacy of preoperative oral antibiotics prophylaxis for preventing surgical site infections in elective colorectal surgery.

Timeline

Start

2019-05-01

Primary completion

2021-11-01

Completion

2021-11-01

Publications

• Background American College of Surgeons. National Surgical Quality Improvement Program Semi-annual report. 2009. Available at: https://acsnsqip.org/login/default.aspx.
• Background Arriaga AF, Lancaster RT, Berry WR, Regenbogen SE, Lipsitz SR, Kaafarani HM, Elbardissi AW, Desai P, Ferzoco SJ, Bleday R, Breen E, Kastrinakis WV, Rubin MS, Gawande AA. The better colectomy project: association of evidence-based best-practice adherence rates to outcomes in colorectal surgery. Ann Surg. 2009 Oct;250(4):507-13. doi: 10.1097/SLA.0b013e3181b672bc.
• Background Csikesz NG, Nguyen LN, Tseng JF, Shah SA. Nationwide volume and mortality after elective surgery in cirrhotic patients. J Am Coll Surg. 2009 Jan;208(1):96-103. doi: 10.1016/j.jamcollsurg.2008.09.006. Epub 2008 Oct 31.
• Background Finlayson EV, Goodney PP, Birkmeyer JD. Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg. 2003 Jul;138(7):721-5; discussion 726. doi: 10.1001/archsurg.138.7.721.
• Background Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.
• Background Slim K, Vicaut E, Launay-Savary MV, Contant C, Chipponi J. Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery. Ann Surg. 2009 Feb;249(2):203-9. doi: 10.1097/SLA.0b013e318193425a.

Drugs

Indications

No indication recorded.