Clinical trial NCT02505581: Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis
Official title: Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Wound Infection
Keywords: Postoperative Wound Infection
Surgical Wound Infection
Colorectal Surgery Infection Prophylaxis
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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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


Eligibility 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)

Primary outcomes:
measure: Wound infection
timeFrame: 30 days
Secondary outcomes:
measure: Hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Direct Adverse Drug Reactions
timeFrame: 24 hours since the drug is taken
measure: Occlusive problems
timeFrame: 30 days from surgery
measure: Iatrogenic problems
timeFrame: 30 days after surgery
measure: Impaired healing
timeFrame: 30 days after surgery
measure: Bleeding problems
timeFrame: 30 days after surgery
measure: Cardiac complications
timeFrame: 30 days after surgery
measure: Nephro-urinary complications
timeFrame: 30 days after surgery
measure: Respiratory complications
timeFrame: 30 days after surgery
measure: Vascular Complications
timeFrame: 30 days after surgery
measure: Gastrointestinal complications
timeFrame: 30 days after surgery
measure: Neurological complications
timeFrame: 30 days after surgery
measure: Local infection
timeFrame: 30 days after surgery
measure: Local complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall d´Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Eloy Espin Basany, MD PhD
role: STUDY_CHAIR
References:
citation: Espin Basany E, Solis-Pena A, Pellino G, Kreisler E, Fraccalvieri D, Muinelo-Lorenzo M, Maseda-Diaz O, Garcia-Gonzalez JM, Santamaria-Olabarrieta M, Codina-Cazador A, Biondo S. Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):729-738. doi: 10.1016/S2468-1253(20)30075-3. Epub 2020 Apr 21.