Status:
COMPLETED
Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery.
Lead Sponsor:
University of Turin, Italy
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 be...
Detailed Description
This study is a Multicenter, Prospective, Randomized, Controlled Trial on preoperative oral antibiotics prophylaxis in colorectal surgery. INCLUSION \& EXCLUSION CRITERIA: All consecutive patients u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04438655
Start Date
May 1 2019
End Date
November 1 2021
Last Update
May 16 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Università degli studi di Torino
Turin, Torino, Italy, 10126