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

Surgical Wound Infection Clinical Trial

— ORALEV  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505581
• Other study ID #: 2014-002345-21
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: November 10, 2018

Study information

• Verified date: January 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: November 10, 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

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

Procedure:
• Colorectal Surgery
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)

Drug:
• Ciprofloxacin 750 mg oral
An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
• Metronidazole 250 mg oral
An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
• Cefuroxime 1.5 g Intravenous
An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
• Metronidazole 1 g Intravenous
An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Vall d´Hebron	Barcelona
Spain	Hospital Universitari de Girona Dr. Josep Trueta	Girona
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound infection	Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently	30 days
Secondary	Hospital stay	Hospital stay since colorectal surgery is done	Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Direct Adverse Drug Reactions	Allergic reactions Intolerance; •This morbidity problems are reported independently as a YES/NO variable	24 hours since the drug is taken
Secondary	Occlusive problems	Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),.... Occlusive problems, Iatrogenic problems, Impaired healing ( Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...) Bleeding problems, Cardiac complications, Nephro-urinary complications, Respiratory complications, Vascular Complications, Gastrointestinal complications, Neurological complications, Local complications...; •This morbidity problems are reported independently as a YES/NO variable	30 days from surgery
Secondary	Iatrogenic problems	Damage to structures such as ureters, bowel loops artery / iliac vein ....; •This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Impaired healing	This is a Clinical measure always supported by image tests.; This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Bleeding problems	Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....; •This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Cardiac complications	acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema; This is a Clinical measure supported by more specific tests if necessary.; This morbidity problems are reported independently as a YES/NO variable; Cardiologist report will be required for including this items	30 days after surgery
Secondary	Nephro-urinary complications	Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...; This is a Clinical measure supported by more specific tests if necessary.; This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Respiratory complications	Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...; This is a Clinical measure always supported by image .; This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Vascular Complications	Deep venous thrombosis, phlebitis, thrombophlebitis, ...; This is a Clinical measure supported by more specific test if necessary .; This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Gastrointestinal complications	Liver failure, gastrointestinal bleeding, severe malnutrition, ...; This is a Clinical measure supported by blood test and further test if necessary; This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Neurological complications	Disorientation, cerebral vascular accident, ...; This is a Clinical measure.; This morbidity problems are reported independently as a YES/NO variable.; Neurologist report will be required beyond disorientation.	30 days after surgery
Secondary	Local infection	Superficial, deep, body-cavity; This is a Clinical measure supported by image if necessary; This morbidity problems are reported independently as a YES/NO variable	30 days after surgery
Secondary	Local complications	Hematoma, seroma, evisceration; This is a Clinical measure.; This morbidity problems are reported independently as a YES/NO variable	30 days after surgery