to compare two preoperatory antibiotic regimens to prevent surgical infections in colon surgery

Phase 1

• Conditions: 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: 17.0Level: PTClassification code 10061779Term: Colon operationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 17.0Level: PTClassification code 10049924Term: Infection prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-002345-21-ES
• Lead Sponsor: Dr Eloy Espin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-03
• Study Completion: 2017-04-28
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 536

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified