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 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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002002-43-ES

Enrollment

108

Registered

2019-10-21

Start date

2019-12-16

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing right hemicolectomy MedDRA version: 21.1 Level: LLT Classification code 10039153 Term: Right hemicolectomy System Organ Class: 100000004865

Interventions

Trade Name: CitraFleet Pharmaceutical Form: Concentrate for oral solution INN or Proposed INN: SODIUM PICOSULFATE CAS Number: 10040-45-6

Eligibility

Sex/Gender

All

Inclusion 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

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®.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine the efficacy in terms of surgical site infection reduction for the use of oral and intravenous antibiotic prophylaxis associated with mechanical preparation of the colon, compared with the use of antibiotic only intravenously or the association of antibiotic therapy oral and intravenous without mechanical preparation, in the surgical procedure of right hemicolectomy.; Secondary Objective: Assess differences between the three groups in relation to anastomotic dehiscence rate Assess differences between the three groups in relation to post-surgical hospital stay Assess differences between the three groups in relation to global complications in the immediate postoperative period ; Primary end point(s): Temperature Appearance of surgical wound Abdominal examination C-reactive protein Surgical wound culture ;Timepoint(s) of evaluation of this end point: daily up to 30 days after surgery	—

Measure

Time frame

Main Objective: Determine the efficacy in terms of surgical site infection reduction for the use of oral and intravenous antibiotic prophylaxis associated with mechanical preparation of the colon, compared with the use of antibiotic only intravenously or the association of antibiotic therapy oral and intravenous without mechanical preparation, in the surgical procedure of right hemicolectomy.; Secondary Objective: Assess differences between the three groups in relation to anastomotic dehiscence rate Assess differences between the three groups in relation to post-surgical hospital stay Assess differences between the three groups in relation to global complications in the immediate postoperative period ; Primary end point(s): Temperature Appearance of surgical wound Abdominal examination C-reactive protein Surgical wound culture ;Timepoint(s) of evaluation of this end point: daily up to 30 days after surgery

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: For 30 days after surgery; Secondary end point(s): Anastomotic dehiscence rate Duration of the post-surgical hospital stay Global Complication Rate	—

Countries

Spain

Contacts

Public ContactUnidad de Investigación Clínica

Fundación Instituto de Investigación Sanitaria Aragón

pmillan@iisaragon.es0034976713259

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026