E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colon preparation for colonoscopy |
preparación del colon para colonoscopia |
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E.1.1.1 | Medical condition in easily understood language |
Bowel preparation for colonoscopy |
Preparación del intestino para colonoscopia |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010007 |
E.1.2 | Term | Colonoscopy |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
To compare the efficacy of a multidisciplinary approach (education, low fiber diet, PEG 2L bisacodyl and adjuvant) versus a conventional approach (low fiber diet plus PEG 4 L) in cleaning the colon of hospitalized patients |
Comparar la eficacia de un abordaje pluridisciplinar (educación, dieta sin fibra, PEG 2L, bisacodilo y adyuvante) vs un abordaje convencional (dieta sin fibra + PEG 4L fraccionados) en la limpieza del colon de pacientes hospitalizados. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Hospitalized patients who undergo a non urgent colonoscopy 2. Patients who give informed consent to participate in the study 3. Patients older than 18 years 4. Patients who undergo total colonoscolpy |
1. Todos los pacientes hospitalizados a los que se les solicita una colonoscopia de forma no urgente. 2. Obtención del consentimiento informado para participar al ensayo clínico 3. Edad superior a los 18 años. 4. Indicación de colonoscopia total. |
|
E.4 | Principal exclusion criteria |
1. Non compliance with the 48 hours diet prescribed 2. The endoscopy planned is a rectosigmoidoscopy 3. Previous colonic surgery 4. Mental/cognitive impairment preventing tthe study assessments 5. Severe renal failure 6. Electrolitic disbalance (hyponatremia, hypokaliemia, Hyperfosfatemia, hypocalcemia and hypomagnesemia) 7. Intestinal obstruction, perforation or toxic megacolon 8. Pregnant or nursing women 9. Alergy/intolerance to PEG, bisacodyl or adjuvants 10. No informed consent |
1. Cumplimiento dietético por debajo de 48 h 2. Indicación de rectosigmoidoscopia 3. Pacientes con intervención quirúrgica colónica previa. 4. Déficit cognitivo/mental que impide la valoración de la respuesta /tolerancia. 5. Insuficiencia renal grave 6. Alteracion electrolítica ( hiponatremia, hipokaliemia, hiperfosfatemia, hipocalcemia e hipomagnesemia) 7. Obstrucción intestinal, perforación intestinal, megacolon tóxico. 8. Embarazo, lactancia. 9. Alergia/Intolerancia a la preparación (PEG), bisacodilo, ó adyuvantes. 10. Ausencia de consentimiento informado. |
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E.5 End points |
E.5.1 | Primary end point(s) |
percentage of patients with adequate bowel preparation, defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale) |
Tasa de pacientes con limpieza adecuada del colon. Se define limpieza adecuada del colon como la que nos permite explorar toda la mucosa colónica, haciendo posible detectar lesiones planas (limpieza buena o excelente en la escala de Boston). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The evaluation of this endpoint will be during the colonoscopy |
Se evaluará durante la colonoscopia |
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E.5.2 | Secondary end point(s) |
Percentage of patients with adequate bowel preparation by bowel segments, tolerance to the colonoscopy, colonoscopy findings, percentage of complete/uncomplete colonoscopies and reprogramming, complications during and after the procedure, doses of sedation needed during the colonoscopy |
tasa de pacientes con limpieza adecuada del colon por segmentos, tolerancia del paciente a la preparación, tolerancia a la colonoscopia, duración de la colonoscopia, hallazgos endoscópicos, porcentaje de colonoscopias completa/incompleta y porcentaje de reprogramación, complicaciones durante y posteriores al procedimiento, dosis de fármacos sedantes requeridos durante la colonoscopia. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The evaluation of this endpoint will be during and after the colonoscopy |
Se evaluará durante y posteriormente a la colonoscopia |
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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 | No |
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 | No |
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 |
Abierto para pacientes y ciego para investigador |
Open for patients and blind for the investigator |
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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 |
abordaje convencional |
conventional approach |
|
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
|
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |