Surgical Wound InfectionPhase 4ORALEVNCT02505581
Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis
A Phase 4 study testing Extra dosage - cefuroxime (750mg) I.V, Colorectal Surgery and Ciprofloxacin 750 mg oral in people with Surgical Wound Infection, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Extra dosage - cefuroxime (750mg) I.V, Colorectal Surgery and Ciprofloxacin 750 mg oral
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 3 sitesSpain
- Study dates
- May 2015to 10 Nov 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Patients presenting allergy to the drugs under study.
- Patients that will not strictly follow the assigned prophylaxis regimen
- Patients undergoing urgent surgery (<24h)
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital General Universitario Vall d´Hebron
Barcelona, 08035
Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona
About this study
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)
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.
Read more
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
- Conditions
- Surgical Wound Infection
- Being tested
- Extra dosage - cefuroxime (750mg) I.V, Colorectal Surgery, Ciprofloxacin 750 mg oral, Metronidazole 250 mg oral, Cefuroxime 1.5 g Intravenous
- Keywords
- Postoperative Wound Infection, Surgical Wound Infection, Colorectal Surgery Infection Prophylaxis
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra dosage - cefuroxime (750mg) I.VDrug
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 SurgeryProcedure or surgery
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
Ciprofloxacin 750 mg oralDrug
An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
Metronidazole 250 mg oralDrug
An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
Cefuroxime 1.5 g IntravenousDrug
An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
Metronidazole 1 g IntravenousDrug
An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
| Study group | Role | What they receive |
|---|---|---|
| Oral + Parenteral prophylaxis | Experimental | Not described Receives: Drug: Extra dosage - cefuroxime (750mg) I.V; Procedure: Colorectal Surgery; Drug: Ciprofloxacin 750 mg oral; Drug: Metronidazole 250 mg oral; Drug: Cefuroxime 1.5 g Intravenous; Drug: Metronidazole 1 g Intravenous |
| Only Parenteral prophylaxis | Active comparator | Not described Receives: Drug: Extra dosage - cefuroxime (750mg) I.V; Procedure: Colorectal Surgery; Drug: Cefuroxime 1.5 g Intravenous; Drug: Metronidazole 1 g Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently
Measured: 30 days
Secondary outcomes (14)
Hospital stay
Hospital stay since colorectal surgery is done
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Direct Adverse Drug Reactions
Allergic reactions Intolerance
•This morbidity problems are reported independently as a YES/NO variable
Measured: 24 hours since the drug is taken
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
Measured: 30 days from surgery
Iatrogenic problems
Damage to structures such as ureters, bowel loops artery / iliac vein ....
•This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Impaired healing
- This is a Clinical measure always supported by image tests.
- This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Bleeding problems
Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....
•This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
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
Measured: 30 days after surgery
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
Measured: 30 days after surgery
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
Measured: 30 days after surgery
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
Measured: 30 days after surgery
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
Measured: 30 days after surgery
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.
Measured: 30 days after surgery
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
Measured: 30 days after surgery
Local complications
Hematoma, seroma, evisceration
- This is a Clinical measure.
- This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2017
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eloy Espin Basany, MD PhD, Study chair, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505581
- Sponsor's protocol ID
- 2014-002345-21
- Other IDs
- 2014
- Acronym
- ORALEV
- Status last verified
- Jan 2020
- First submitted
- 15 Jun 2015
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32325012
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02505581
- Acronym / sponsor ID
- ORALEV / 2014-002345-21
- Conditions
- Surgical Wound Infection
- Keywords
- Postoperative Wound Infection, Surgical Wound Infection, Colorectal Surgery Infection Prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral + Parenteral prophylaxis | Experimental | Drug: Extra dosage - cefuroxime (750mg) I.V, Procedure: Colorectal Surgery, Drug: Ciprofloxacin 750 mg oral, Drug: Metronidazole 250 mg oral, Drug: Cefuroxime 1.5 g Intravenous, Drug: Metronidazole 1 g Intravenous |
| Only Parenteral prophylaxis | Active comparator | Drug: Extra dosage - cefuroxime (750mg) I.V, Procedure: Colorectal Surgery, Drug: Cefuroxime 1.5 g Intravenous, Drug: Metronidazole 1 g Intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra dosage - cefuroxime (750mg) I.VIn 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 | Drug | Only Parenteral prophylaxis, Oral + Parenteral prophylaxis |
| Colorectal SurgeryBoth groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria) | Procedure or surgery | Only Parenteral prophylaxis, Oral + Parenteral prophylaxis |
| Ciprofloxacin 750 mg oralAn oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery. | Drug | Oral + Parenteral prophylaxis |
| Metronidazole 250 mg oralAn oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery. | Drug | Oral + Parenteral prophylaxis |
| Cefuroxime 1.5 g IntravenousAn intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction. | Drug | Only Parenteral prophylaxis, Oral + Parenteral prophylaxis |
| Metronidazole 1 g IntravenousAn intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction. | Drug | Only Parenteral prophylaxis, Oral + Parenteral prophylaxis |
Primary outcome
Wound infection
Time frame: 30 days
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently
14 secondary outcomes
Hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Direct Adverse Drug Reactions
Time frame: 24 hours since the drug is taken
Occlusive problems
Time frame: 30 days from surgery
Iatrogenic problems
Time frame: 30 days after surgery
Impaired healing
Time frame: 30 days after surgery
Bleeding problems
Time frame: 30 days after surgery
Cardiac complications
Time frame: 30 days after surgery
Nephro-urinary complications
Time frame: 30 days after surgery
Respiratory complications
Time frame: 30 days after surgery
Vascular Complications
Time frame: 30 days after surgery
Gastrointestinal complications
Time frame: 30 days after surgery
Neurological complications
Time frame: 30 days after surgery
Local infection
Time frame: 30 days after surgery
Local complications
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 32325012Espin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eloy Espin Basany, MD PhD study chair
Hospital Universitari Vall d'Hebron Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extra dosage - cefuroxime (750mg) I.V, Colorectal Surgery and Ciprofloxacin 750 mg oral in people with Surgical Wound Infection, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.