The hypothesis of this study is that using antibiotic prophilaxis with oral antibiotic added to a standard intravenous regimen in colorectal surgery, but without the use of mechanical bowel preparation, could improve the incidence of postoperative septic complications. If this is proved, this could benefit a large number of patients, due to the high prevalence of septic complications in colon surgery, and the high morbidity and mortality associated with these. MedDRA version: 17.0 Level: PT Cla
Conditions
Interventions
Product Name: CIPROFLOXACINO
Pharmaceutical Form: Tablet
INN or Proposed INN: CIPROFLOXACIN
CAS Number: 85721-33-1
Other descriptive name: CIPROFLOXACIN
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Dr Eloy Espin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients over 18 years of age diagnosed with malignant or benign disease with indication for segmental colon resection, or total colectomy for the same indications, without medical contraindication to surgery. Patients who agree to participate voluntarily in the study and signs an informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 336 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: - Patients who refuse to participate in the study. - Patients undergoing mechanical bowel preparation the day before surgery. - Patients with intraabdominal sepsis before surgery (abscess). - Patients who received preoperative antibiotics for any reason within two weeks prior to surgery. - Patients who have allergies to study drugs. - Patients who do not comply strictly with the assigned prophylaxis regimen. - Patients that cannot be followed for at least 4 weeks after surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This clinical trial aims to make an assessment of the effectiveness of oral and intravenous antibiotic prophylaxis in elective colon surgery, compared with administration of intravenous prophylaxis alone. The evaluation of the effectiveness is performed by the prospective recording of septic complications in the postoperative period and following the patient for one month; to determine whether the application of oral and intravenous antibiotic prophylaxis improves the incidence of surgical site infections in colonic surgery in patients who did not receive any mechanical preparation of the colon before surgery.;Secondary Objective: To evaluate the safety and tolerability of such prophylaxis regarding intravenous prophylaxis in patients not receiving mechanical preparation of the colon (comparison of complication rate, type and treatment needed and hospital length of stay between the two regimens of prophylaxis).;Primary end point(s): surgical site infection, perioperative complications: rate, type and treatment needed;Timepoint(s) of evaluation of this end point: 30 days, or during hospital stay if longer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Hospital length of stay, tolerance of treatment;Timepoint(s) of evaluation of this end point: 30 days, or during hospital stay if longer | — |
Countries
Spain
Contacts
Public ContactColorectal Surgery Unit
Dr Eloy Espin
Outcome results
None listed