E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Uncomplicated acute diverticulitis |
Diverticulitis aguda no complicada |
|
E.1.1.1 | Medical condition in easily understood language |
Uncomplicated acute diverticulitis |
Diverticulitis aguda no complicada |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 |
We want to evaluate the efficacy and safety of outpatient management without antibiotics in the context of uncomplicated acute diverticulitis and comparable according to parameters of relapse and rate of complications published in the studies who treat these patients with antibiotics. |
Evaluar la eficacia y seguridad del manejo ambulatorio sin antibióticos en el contexto de diverticulitis aguda no complicada, y observar si es comparable según parámetros de recidiva y tasa de complicaciones a los datos publicados del tratamiento ambulatorio con antibióticos. |
|
E.2.2 | Secondary objectives of the trial |
Secondary variables will be recurrence of acute diverticulitis within the first year after treatment of the study episode (radiological confirmation with new abdominal CT) or mortality due to disease within 12 months after discharge. |
Las variables secundarias serán la recidiva de episodio de diverticulitis aguda dentro del primer año tras el tratamiento del episodio de estudio (confirmación radiológica con nuevo TC abdominal) o mortalidad debida a causa de la enfermedad en los siguientes doce meses después del alta |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years with diagnosis of type Ia diverticulitis (modified Hinchey)
Patients who sign informed consent |
Pacientes mayores de 18 años con diagnóstico de diverticulitis tipo Ia (Hinchey modificada)
Pacientes que firmen el consentimiento informado |
|
E.4 | Principal exclusion criteria |
Diverticulitis Ib: pericolic abscess, II: pelvic, intra-abdominal or retroperitoneal abscess, III: purulent peritonitis, IV: fecaloid peritonitis.
Pregnancy or breastfeeding.
Previous antibiotic treatment in the previous month for another cause.
Second episode of diverticulitis.
Suspicion of colon cancer.
Immunosuppressive status (treatment with corticosteroids, immunosuppressants,
Drugs, transplanted, renal failure with hemodialysis, immunodeficiencies
Congenital or acquired.
Cognitive deficit.
Refusal to sign informed consent.
Rejection to protocolized follow-up.
Violation of assigned treatment. |
Diverticulitis más severa que tipo Ia (Hinchey modificada): Diverticulitis Ib: absceso pericólico, II: absceso pélvico, intrabdominal o retroperitoneal, III: peritonitis purulenta, IV: peritonitis fecaloidea.
Embarazo o lactancia.
Tratamiento antibiótico previo en el mes anterior por otra causa.
Segundo episodio de diverticulitis.
Sospecha de cáncer de colon.
Estado de inmunosupresión (tratamiento con corticoides, inmunosupresores,
drogas, trasplantados, insuficiencia renal con hemodiálisis, inmunodeficiencias
congénitas o adquiridas.
Déficit cognitivo.
Rechazo a firmar el consentimiento informado.
Rechazo al seguimiento protocolizado.
Violación del tratamiento asignado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
La principal variable del estudio será evaluar el fallo del tratamiento. |
The main variable of the study will be to evaluate the treatment failure. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Las variables secundarias serán la recidiva de episodio de diverticulitis aguda dentro del primer año tras el tratamiento del episodio de estudio (confirmación radiológica con nuevo TC abdominal) o mortalidad debida a causa de la enfermedad en los siguientes doce meses después del alta. |
Secondary variables will be recurrence of acute diverticulitis within of the first year after the treatment of the study episode (radiological confirmation) or mortality due to the disease in the twelve months after discharge. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Estudio comparativo de tratamiento antibiótico habitual contra no tratamiento |
Comparative treatment with usually antibiotic with no treatment |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Estudio comparativo de tratamiento antibiótico habitual contra no tratamiento |
Comparative treatment with usually antibiotic with no treatment |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | Yes |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |