Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis
ORALEV
Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)
1 other identifier
interventional
536
1 country
3
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. \+ 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2015
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2018
CompletedJanuary 14, 2020
January 1, 2020
1.9 years
June 15, 2015
January 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Direct Adverse Drug Reactions
24 hours since the drug is taken
Occlusive problems
30 days from surgery
Iatrogenic problems
30 days after surgery
Impaired healing
30 days after surgery
- +9 more secondary outcomes
Study Arms (2)
Oral + Parenteral prophylaxis
EXPERIMENTALOnly Parenteral prophylaxis
ACTIVE COMPARATORInterventions
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
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario Vall d´Hebron
Barcelona, 08035, Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007, Spain
Related Publications (1)
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.
PMID: 32325012DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eloy Espin Basany, MD PhD
Hospital Universitari Vall d'Hebron Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2015
First Posted
July 22, 2015
Study Start
May 1, 2015
Primary Completion
April 1, 2017
Study Completion
November 10, 2018
Last Updated
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share