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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Anti-Bacterial Agents

Criteria

Inclusion criteria:

• Summary: All consecutive patients undergoing colorectal resection should be included.

• Age: Age 18 years or above.

• The general health condition of the patient permits general anesthesia (ASA- classification I-III).

• Absence of allergy to the oral antibiotics employed

• Timing: Elective procedures.

• Technique: Open, laparoscopic, laparoscopic-assisted or laparoscopic converted to open.

• Returns to theatre: Each patient should only be included in the study once. Return to theatre during the same admission or follow up should be collected as a complication.

• Included procedures: Any colorectal resection (See Appendix B).

• Mechanical Bowel Preparation: Any mechanical bowel preparation (as indicated by each centre).

Exclusion criteria:

• Emergency procedures

• Appendicectomy (unless procedure involves a right hemicolectomy)

• Primarily urological/gynecological or vascular procedure - e.g. ileal conduit, Hartmann's during ovarian surgery, resection during abdominal aortic aneurysm repair.

• Diagnostic laparotomy/laparoscopy without intestinal resection.

• Surgery involving multi-visceral surgery - e.g. pelvic exenteratio

• Controindication for mechanical preparation

• Allergy to used drugs (neomycin sulfate, amoxicillin-clavulanic acid)

• Patients who refuse to participate in the study

• Patients with intra-abdominal sepsis before surgery (abscess).

• Patients who received antibiotics for any reason within two weeks prior to surgery.

• Patients who do not comply strictly with the assigned prophylaxis regimen.

• Patients who cannot be followed at least 4 weeks after surgery.