EUCTR2019‐002002‐43‐ES.

Study name	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
Methods	Study type: interventional clinical trial of medicinal product Study design Controlled: yes Randomised: yes Open: yes Single blind: no Double‐blind: no If controlled, specify comparator, Other Medicinal Product: yes Placebo: no Number of treatment arms in the trial: 3
Participants	Condition or disease: patients undergoing right hemicolectomy Inclusion criteria Patients older than 18 years with surgical indication of right hemicolectomy who do not present any exclusion criteria. Exclusion criteria Patients under 18 years Urgent colorectal resections. Patients presenting an occlusive or sub‐occlusive condition at the time of surgery. Patient who does not meet the inclusion criteria in the intensified recovery program based on the RICA route (Intensified Recovery in Abdominal Surgery) Patients undergoing colonic resection that involve a location other than the right colon. Patients affected by intra‐abdominal or distant infection prior to surgery. Patients who have been given antibiotics for any other indication during the two weeks prior to the intervention. Patient with inflammatory bowel disease. Pregnant or breastfeeding patient. Patients with immunity disorders or receiving immunosuppressive treatment or with synchronous neoplasms of other organs at the time of surgery. Previous history of allergy to erythromycin, neomycin or derivatives, as well as Citrafleet®. Target sample size: 108
Interventions	Treatment arms CitraFleet Eritromicina Neomicina
Outcomes	Primary outcomes Temperature Appearance of surgical wound Abdominal examination C‐reactive protein Surgical wound culture Secondary outcomes Anastomotic dehiscence rate Duration of the post‐surgical hospital stay Global Complication Rate Time point(s) of evaluation the end point(s): for 30 days after surgery
Starting date	Date of registration: 21/10/2019 Study Start Date: 16/12/2019 Study Completion Date: ‐ Recruitment Status: authorised‐recruitment may be ongoing or finished
Contact information	Contact person: P. Millan (Unidad de Investigación Clínica) Affiliation: Fundación Instituto de Investigación Sanitaria Aragón Country of origin: Spain
Notes	Ethics approval: Favourable Ethics Committee Opinion of the trial application (2019‐12‐12) Source of funding: Fundación Instituto de Investigación Sanitaria Aragón