Randomized study of three treatment arms; Colon mechanical preparation with oral and intravenous antibiotics versus oral and intravenous or only intravenous antibiotics. To confirm the decrease of infections in the surgical site with the first of the treatment arm after colon surgery.

Phase 1

• Conditions: Patients undergoing right hemicolectomy; MedDRA version: 21.1 Level: LLT Classification code 10039153 Term: Right hemicolectomy System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-002002-43-ES
• Lead Sponsor: Fundación Instituto de Investigación Sanitaria Aragón

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-21
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 108

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®.

Study & Design

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