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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 4

Conditions: Surgical Wound Infection

Treatments: Drug: Metronidazole 1 g Intravenous; Drug: Extra dosage - cefuroxime (750mg) I.V; Drug: Metronidazole 250 mg oral; Procedure: Colorectal Surgery; Drug: Cefuroxime 1.5 g Intravenous; Drug: Ciprofloxacin 750 mg oral

Study type: Interventional

Funder types: Other

Identifiers

NCT02505581

2014-002345-21

Details and patient eligibility

About

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

Enrollment: 536 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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536 participants in 2 patient groups

Oral + Parenteral prophylaxis

Experimental group

Treatment:

Drug: Metronidazole 1 g Intravenous

Procedure: Colorectal Surgery

Drug: Cefuroxime 1.5 g Intravenous

Drug: Extra dosage - cefuroxime (750mg) I.V

Drug: Metronidazole 250 mg oral

Drug: Ciprofloxacin 750 mg oral

Only Parenteral prophylaxis

Active Comparator group

Treatment:

Drug: Metronidazole 1 g Intravenous

Procedure: Colorectal Surgery

Drug: Cefuroxime 1.5 g Intravenous

Drug: Extra dosage - cefuroxime (750mg) I.V