NCT04438655: COLORAL1

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

Completed NA Last updated 16 May 2023

What this trial tests

NA trial testing Oral antibiotic drugs in Colorectal Surgery in 130 participants. Completed in 1 November 2021.

Timeline

1 May 2019

Primary endpoint
1 November 2021

1 November 2021

Quick facts

Lead sponsor	University of Turin, Italy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	130
Start date	1 May 2019
Primary completion	1 November 2021
Estimated completion	1 November 2021
Sites	1 location across Italy

Drugs / interventions tested

• Oral antibiotic drugs — full drug profile →
• Parenteral prophylaxis — full drug profile →

Conditions studied

• Colorectal Surgery — all drugs for Colorectal Surgery →

Sponsor

University of Turin, Italy

Who can join

18 and older, any sex, with Colorectal Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery.
   Willis MA, Toews I, Soltau SL, Kalff JC, et al · · 2023 · cited 46× · PMID 36748942 · DOI 10.1002/14651858.cd014909.pub2
2. Oral neomycin and bacitracin are effective in preventing surgical site infections in elective colorectal surgery: a multicentre, randomized, parallel, single-blinded trial (COLORAL-1).
   Arezzo A, Mistrangelo M, Bonino MA, Salusso P, et al · · 2021 · cited 10× · PMID 34148172 · DOI 10.1007/s13304-021-01112-5
3. Abstracts from the 29th International Congress of the European Association for Endoscopic Surgery (EAES), Barcelona, Spain, 24–27 November 2021
   · 2022