E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Laparoscopic colorectal surgery |
Cirugía colorrectal laparoscópica |
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E.1.1.1 | Medical condition in easily understood language |
Keyhole surgery of the large intestine |
Cirugía laparoscópica del intestino grueso |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 |
Main study: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery with perioperative care according to the enhanced recovery principles. |
Estudio principal: establecer la relación entre el uso de neumoperitoneo de baja presión con bloqueo neuromuscular profundo y la calidad temprana de la recuperación después de la cirugía colorrectal laparoscópica con cuidados perioperatorios de acuerdo con los principios de recuperación precoz. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
RECOVER PLUS: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and innate immune function after laparoscopic colorectal surgery.
Version 2, 02-05-2018 |
RECOVER PLUS: para establecer la relación entre el uso de neumoperitoneo de baja presión con bloqueo neuromuscular profundo y la función inmune innata después de la cirugía colorrectal laparoscópica.
Versión 2, 02-05-2018 |
|
E.3 | Principal inclusion criteria |
- Scheduled for laparoscopic colorectal surgery with a primary anastomosis - Age ≥ 18 years - Obtained informed consent |
- Cirugía colorrectal laparoscópica programado con anastomosis primaria. - Edad ≥ 18 años - Consentimiento informado obtenido |
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E.4 | Principal exclusion criteria |
- Insufficient control of the local language to read the patient information and to fill out the questionnaires - Primary colostomy - Neo-adjuvant chemotherapy (substudy) - Chronic use of analgesics or psychotropic drugs - Use of NSAIDs shorter than 5 days before surgery - Known or suspected allergy to rocuronium of sugammadex - Neuromuscular disease - Indication for rapid sequence induction - Severe liver- or renal disease (creatinine clearance <30ml/min) - BMI >35 kg/m² - Deficiency of vitamin K dependent clotting factors or coagulopathy |
- Insuficiente control del idioma local para leer la información del paciente y completar los cuestionarios. - Colostomía primaria - Quimioterapia neoadyuvante (subestudio) - Uso crónico de analgésicos o psicotrópicos. - Uso de AINE menos de 5 días antes de la cirugía. - Alergia conocida o sospechada al rocuronio de sugammadex - Enfermedad neuromuscular - Indicación de inducción de secuencia rápida. - Enfermedad hepática o renal grave (aclaramiento de creatinina <30 ml / min) - IMC> 35 kg / m² - Deficiencia de factores de coagulación dependientes de la vitamina K o coagulopatía |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quality of recovery (QoR-40) questionnaire score Substudy: mononuclear cell activity ex vivo measured as IL-6 and IL-10 production upon LPS stimulation. |
Puntuación del cuestionario de calidad de recuperación (QoR-40) Subestudio: actividad de células mononucleares ex vivo medida como producción de IL-6 e IL-10 tras estimulación con LPS. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours after surgery |
24 horas después de la cirugía |
|
E.5.2 | Secondary end point(s) |
• Quality of recovery-40 questionnaire score • McGill Pain questionnaire • RAND-36 general health questionnaire • Pain at rest and pain on movement (NRS 0-10), is pain acceptable or unacceptable, referred shoulder pain yes/no • Postoperative nausea and vomiting (NRS 0-10) • Cumulative opiate, analgesic and anti-emetics use • Length of hospital stay • Post-operative complications • Surgical conditions; the Surgical Rating Scale is used to quantify the quality of the surgical field during the pneumoperitoneum phase • Time to reach discharge criteria
Substudy: • Peritoneal mesothelial hypoxia as reflected by peritoneal HIF1α mRNA expression. • Histological peritoneal mesothelial cell injury and plasma levels of DAMPs and cytokines. |
• Calidad de la puntuación del cuestionario Recovery-40 • Cuestionario McGill Pain • Cuestionario de salud general RAND-36 • Dolor en reposo y dolor en el movimiento (NRS 0-10), es dolor aceptable o inaceptable, dolor de hombro referido sí / no • Náuseas y vómitos postoperatorios (NRS 0-10) • Uso acumulativo de opiáceos, analgésicos y antieméticos. • Duración de la estancia hospitalaria. • Complicaciones postoperatorias • Condiciones quirúrgicas; La Escala de Valoración Quirúrgica se utiliza para cuantificar la calidad del campo quirúrgico durante la fase de neumoperitoneo. • Tiempo para alcanzar los criterios de alta
Subestudio: • Hipoxia mesotelial peritoneal reflejada por la expresión peritoneal de ARNm de HIF1α. • Lesión histológica de células mesoteliales peritoneales y niveles plasmáticos de DAMP y citocinas. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Quality of recovery-40 questionnaire score day 3 and 7 after surgery • McGill Pain and RAND-36 questionnaires upon admission and 3 months after surgery. • Pain scores, nausea and vomiting 1, 8, 24 and 72 hours after surgery • Cumulative opiate, analgesic and anti-emetics use and length of hospital stay at discharge • Post-operative complications after 3 months • Surgical conditions during pneumoperitoneum • Time to reach discharge criteria at 8, 24, 48 and 72 hours after surgery
Substudy: • Peritoneal mesothelial hypoxia: HIF1α mRNA expression before and after pneumoperitoneum phase. • Histological peritoneal mesothelial cell injury before and after pneumoperitoneum phase, plasma DAMPs and cytokines upon admission, before and after pneumoperitoneum and 24h after surgery. |
•Puntuación del Recovery-40 días 3 y 7 después de la cirugía • Cuestionarios McGill Pain y RAND-36 al ingreso y 3 meses tras la cirugía. • Puntuaciones de dolor, náuseas y vómitos 1, 8, 24 y 72 horas tras la cirugía. • Uso de opiáceos, analgésicos y antieméticos y duración de la estancia hospitalaria al alta. • Complicaciones postoperatorias tras 3 meses. • Condiciones quirúrgicas durante el neumoperitoneo. • Tiempo para alcanzar los criterios de alta: 8, 24, 48 y 72 horas tras la cirugía.
Subestudio: • Hipoxia mesotelial peritoneal: expresión de ARNm HIF1α antes y después del neumoperitoneo. • Lesión histológica de células mesoteliales peritoneales antes y tras la el neumoperitoneo, DAMP en plasma y citocinas al ingreso, antes y después de neumoperitoneo y 24 h tras la cirugía. |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
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 | 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 | 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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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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LVLS |
Última visita 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |