Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

• Status: Completed
• Trial end date: 2018-11-10
• Target enrollment: 0
• Participant gender: All

Summary

Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used.

Experimental group: Patients undergoing elective colorectal surgery that involves, colonic resection.

The antibiotic prophylaxis in this group will be composed of:

An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery.

+

Control group: Patients undergoing elective colorectal surgery that involves, colonic resection.

The antibiotic prophylaxis in this group will be composed of:

An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction.

In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc.

There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefuroxime; Cefuroxime axetil; Ciprofloxacin; Metronidazole

Criteria

Inclusion Criteria:

• Patients presenting colonic pathology

• The surgery is not contraindicated

• Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..)

• Indication of segmentary resection or total colectomy

• Patients who agree to participate voluntarily in the study and signed an informed consent.

Exclusion Criteria:

• Patients who refuse to participate in the study.

• Patients undergoing mechanical colon preparation the day before surgery.

• Patients with rectal cancer

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

• Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery.

• Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis)

• Patients presenting allergy to the drugs under study.

• Patients that will not strictly follow the assigned prophylaxis regimen

• Patients undergoing urgent surgery (<24h)