EUCTR2019-002002-43-ESActive, not recruitingPhase 1
Phase IV, unicentric, randomized and open study to confirm the decrease of the incidence of the surgical site infection after elective right hemicolectomy with anterographic mechanical preparation associated with oral and intravenous antibiotic therapy versus oral and intravenous antibiotic and versus only intravenous antibiotic
Fundación Instituto de Investigación Sanitaria Aragón0 sites108 target enrollmentStarted: October 21, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 108
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients older than 18 years with surgical indication of right hemicolectomy who do not present any exclusion criteria.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
Exclusion Criteria
- •1. Patients under 18 years.
- •2. Urgent colorectal resections.
- •3. Patients presenting an occlusive or sub-occlusive condition at the time of surgery.
- •4. Patient who does not meet the inclusion criteria in the intensified recovery program based on the RICA route (Intensified Recovery in Abdominal Surgery)
- •5. Patients undergoing colonic resection that involve a location other than the right colon.
- •6. Patients affected by intra-abdominal or distant infection prior to surgery.
- •7. Patients who have been given antibiotics for any other indication during the two weeks prior to the intervention.
- •8. Patient with inflammatory bowel disease.
- •9. Pregnant or breastfeeding patient.
- •10. Patients with immunity disorders or receiving immunosuppressive treatment or with synchronous neoplasms of other organs at the time of surgery.
- •11. Previous history of allergy to erythromycin, neomycin or derivatives, as well as Citrafleet®.
Investigators
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