E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative paralytic Ileus |
Ilieo paralítico postoperatorio |
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E.1.1.1 | Medical condition in easily understood language |
Postoperative paralytic ileus |
Ilieo paralítico postoperatorio |
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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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033841 |
E.1.2 | Term | Paralytic ileus |
E.1.2 | System Organ Class | 100000004856 |
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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 |
Study the effect of Gastrografin on the duration of postoperative ileus in patients that have been submitted to abdominal surgery, versus conventional conservative treatment. |
Evaluar el efecto sobre la duración del íleo paralítico en los pacientes intervenidos de cirugía abdominal (sin anastomosis) del Gastrografin® en comparación con el tratamiento conservador convencional. |
|
E.2.2 | Secondary objectives of the trial |
1) Compare hospital stay (days) between patients who have received Gastrografin versus the ones that have received the conservative treatment. 2) Compare the incidence of complications due to postoperative ileus (dehydration, accute renal insufficiency, complications derived from the nasogastric tube placement or parenteral nutrition) between the two groups. |
1) Comparar el tiempo de estancia hospitalaria entre los pacientes a los que se les administra Gastrografin® y los pacientes que reciben tratamiento convencional. 2) Comparar la aparición de complicaciones derivadas del íleo paralítico como son la deshidratación, insuficiencia aguda de origen prerrenal, complicaciones derivadas del uso de sonda nasogástrica y/o nutrición parenteral entre los dos grupos de tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients older than 18 years old. - Postoperative ileus. - Patients that have been submitted to abdominal surgery (including digestive, vascular, gynecologic or urologic procedures). Patients operated for colorectal surgery with protective ostomy. - Signed informed consent. |
- Mayores de 18 años. - Posoperatorio de cirugía abdominal (incluso vascular, ginecológica o urológica) sin anastomosis intestinal. Posoperados de cirugía colorectal con ostomía de protección. - Íleo paralítico. - Consentimiento de participación en el estudio firmado. |
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E.4 | Principal exclusion criteria |
- Patients undergoing abdominal surgery that includes intestinal anastomosis without protective ostomy. - Pregnancy or lactancy. - Mechanical bowel obstruction. - Intestinal isquemia - Allergy to Gastrografin® (or other radiological contrast) or other situation detailed in the Gastrografin's datasheet that contraindicate its use. - Postoperative complications that could cause paralytic ileus by themselves. (intraabdominal abscess, intraabdominal haematoma,...). - Patients in whose participation in the clinical trial could cause any damage to their health (based on medical criteria) - Severe renal failure - Severe cardiac failure |
- Anastomosis sin ostomía de protección. - Embarazo o lactancia. - Oclusión mecánica. - Isquemia intestinal. - Alergia al Gastrografin® o al contraste o cualquier situación que, según la ficha técnica de Gastrografin®, contraindique su administración. - Complicaciones posoperatorias que justifiquen el íleo paralítico por si mismas (absceso intraabdominal, hematoma intraabdominal,...). - Pacientes en los que se considere que la participación en el estudio pueda suponer un perjuicio clínico, según el médico responsable del paciente. - Insuficiencia renal grave - Insuficiencia cardíaca grave |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to ressolution of postoperative ileus to, defined by prolonged tolerance of P3 diet during 48 hours. |
Tiempo desde el diagnóstico de íleo paralítico hasta la resolución del mismo determinada por: tolerancia prolongada de dieta tipo P3 durante 48h. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The study endpoints will be assessed continuously up to the ressolution of the ileus. The follow-up of the patient is going to consist in, at least, one visit per day. The tolerance of P3 diet must be prolonged at least 48 hours. The moment when the patient accomplish this condition is going to be recordered. |
Las valoraciones del estudio se valorarán de forma continuada hasta la resolución del ileo. El seguimiento del paciente consistirá en como mínimo una visita al día. La tolerancia a la dieta P3 deberá ser prolongada como mínimo durante 48 horas. Se registrará el momento en que el paciente alcanza esta condición. |
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E.5.2 | Secondary end point(s) |
- Time to hospital discharge. - Complications related with postoperative ileus - Time to first deposition after the appearance of postoperative ileus. |
- Tiempo de estancia hospitalaria - Aparición de complicaciones. - Tiempo hasta la realización de deposiciones |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The study endpoints will be assessed continuously up to the ressolution of the ileus and hospital discharge. The follow-up of the patient is going to consist in, at least, one visit per day. The tolerance of P3 diet must be prolonged at least 48 hours. |
Las valoraciones del estudio se realizarán de forma continuada hasta la resolución del íleo y el alta del paciente. El seguimiento del paciente consistirá en como mínimo una visita al día. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
| 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
|
- Last patient last assessment |
última valoración del último paciente |
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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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |