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

NCT04438655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-05-16

No results posted yet for this study

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.

Conditions

  • Colorectal Surgery

Interventions

DRUG

Oral antibiotic drugs

Oral antibiotic drugs: \- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.

DRUG

Parenteral prophylaxis

Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery. in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Alberto Arezzo, Prof. · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-11-01
Completion
2021-11-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438655 on ClinicalTrials.gov