E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing right hemicolectomy |
Pacientes sometidos a hemicolectomía derecha |
|
E.1.1.1 | Medical condition in easily understood language |
Patients who are going to have surgery on the colon |
Pacientes que van a ser intervenidos quirúrgicamente de colon |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039153 |
E.1.2 | Term | Right hemicolectomy |
E.1.2 | System Organ Class | 100000004865 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Establecer la eficacia en términos de reducción de infección de sitio quirúrgico del uso de profilaxis antibiótica (AB) vía oral e intravenosa asociado a preparación mecánica del colon, en comparación con el uso de AB únicamente por vía intravenosa (IV) o la asociación de antibioterapia oral e intravenosa sin PMC, en el procedimiento quirúrgico de hemicolectomía derecha. |
|
E.2.2 | Secondary objectives of the trial |
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 |
Valorar diferencias entre los tres grupos en relación a tasa de dehiscencia anastomótica Valorar diferencias entre los tres grupos en relación a estancia hospitalaria postquirúrgica Valorar diferencias entre los tres grupos en relación a complicaciones globales en el postoperatorio inmediato |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years with surgical indication of right hemicolectomy who do not present any exclusion criteria. |
Pacientes mayores de 18 años con indicación quirúrgica de hemicolectomía derecha que no presenten ningún criterio de exclusión. |
|
E.4 | Principal 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®. |
1. Pacientes menores de 18 años. 2. Resecciones colorrectales de carácter urgente. 3. Pacientes que presenten un cuadro oclusivo o suboclusivo en el momento de la cirugía. 4. Paciente que no cumpla criterios de inclusión en el programa de recuperación intensificada basado en la vía RICA (Recuperación Intensificada en Cirugía Abdominal) 5. Pacientes sometidos a resección colónicas que impliquen otra localización diferente a colon derecho. 6. Pacientes afectados por infección intraabdominal o a distancia previa a la cirugía. 7. Pacientes a los que se ha administrado antibiótico por cualquier otra indicación durante las dos semanas previas a la intervención. 8. Paciente portador de enfermedad inflamatoria intestinal. 9. Paciente embarazada o en periodo de lactancia. 10. Pacientes con alteraciones de la inmunidad o que reciban tratamiento inmunosupresor o con neoplasias sincrónicas de otros órganos en el momento de la cirugía. 11. Historia previa de alergia a la eritromicina, neomicina o derivados, así como a Citrafleet®. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Temperature Appearance of surgical wound Abdominal examination C-reactive protein Surgical wound culture |
Temperatura Aspecto de la herida quirúrgica Exploración abdominal Proteína C Reactiva Cultivo de herida quirúrgica |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
daily up to 30 days after surgery |
Diariamente hasta 30 días tras la cirugia |
|
E.5.2 | Secondary end point(s) |
Anastomotic dehiscence rate Duration of the post-surgical hospital stay Global Complication Rate |
Tasa de dehiscencia Anastomótica Duración de la Estancia hospitalaria postquirúrgica Tasa de Complicaciones globales |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For 30 days after surgery |
Durante 30 días tras la cirugía |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |