Skip to main content
OpenTrials
Completed

NCT Number: NCT02505581

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Extra dosage - cefuroxime (750mg) I.V

Drug

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

Procedure

Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)

Ciprofloxacin 750 mg oral

Drug

An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.

Metronidazole 250 mg oral

Drug

An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.

Cefuroxime 1.5 g Intravenous

Drug

An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.

Metronidazole 1 g Intravenous

Drug

An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.

Primary outcomes

  1. 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

Secondary outcomes

  1. Hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    Hospital stay since colorectal surgery is done

  2. Direct Adverse Drug Reactions

    Time frame: 24 hours since the drug is taken

    Allergic reactions Intolerance

    •This morbidity problems are reported independently as a YES/NO variable

  3. Occlusive problems

    Time frame: 30 days from surgery

    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

  4. Iatrogenic problems

    Time frame: 30 days after surgery

    Damage to structures such as ureters, bowel loops artery / iliac vein ....

    •This morbidity problems are reported independently as a YES/NO variable

  5. Impaired healing

    Time frame: 30 days after surgery

    • This is a Clinical measure always supported by image tests.
    • This morbidity problems are reported independently as a YES/NO variable

  6. Bleeding problems

    Time frame: 30 days after surgery

    Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....

    •This morbidity problems are reported independently as a YES/NO variable

  7. Cardiac complications

    Time frame: 30 days after surgery

    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

  8. Nephro-urinary complications

    Time frame: 30 days after surgery

    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

  9. Respiratory complications

    Time frame: 30 days after surgery

    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

  10. Vascular Complications

    Time frame: 30 days after surgery

    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

  11. Gastrointestinal complications

    Time frame: 30 days after surgery

    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

  12. Neurological complications

    Time frame: 30 days after surgery

    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.

  13. Local infection

    Time frame: 30 days after surgery

    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

  14. Local complications

    Time frame: 30 days after surgery

    Hematoma, seroma, evisceration

    • This is a Clinical measure.
    • This morbidity problems are reported independently as a YES/NO variable

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)

Acronym: ORALEV

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.