Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis
NCT ID: NCT02505581
Last Updated: 2020-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
536 participants
INTERVENTIONAL
2015-05-31
2018-11-10
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Oral + Parenteral prophylaxis
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
Colorectal Surgery
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
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.
Only Parenteral prophylaxis
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
Colorectal Surgery
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
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.
Interventions
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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
Colorectal Surgery
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Eloy Espin Basany, MD PhD
Role: STUDY_CHAIR
Hospital Universitari Vall d'Hebron Research Institute
Locations
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Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario Vall d´Hebron
Barcelona, , Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, , Spain
Countries
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References
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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.
Other Identifiers
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2014-002345-21
Identifier Type: -
Identifier Source: org_study_id
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