E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pneumoperitoneum Pressure in Colorectal laparoscopic surgery |
Presión de insuflación del pneumoperitoneo en cirugía laparoscópica colorectal |
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E.1.1.1 | Medical condition in easily understood language |
Pneumoperitoneum Pressure in minimally invasive Colorectal surgery |
Presión de insuflación del pneumoperitoneo en cirugía colorectal mínimamente invasiva |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
To assess the post-operative recovery quality of the Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery (PQRS- Postoperative Quality of Recovery Scale) within 15 minutes (T15) and 40 minutes (T40) of their stay in the Post-Anaesthesia Recovery Unit and the day 1 (POD1) and day 3 (POD3) of the postoperative (POD- Postoperative Day) |
Evaluar la calidad de la recuperación postoperatoria de la estrategia de individualización de la PIA respecto a una estrategia estándar mediante una escala validada de calidad de recuperación postoperatoria (PQRS- Postoperative Quality of Recovery Scale) a los 15 minutos (T15) y a los 40 minutos (T40) de su estancia en la Unidad de Recuperación postanestésica y el día 1(POD1) y dia 3 (POD3) del postoperatorio |
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E.2.2 | Secondary objectives of the trial |
IAP during surgery in the individualized grup;PV0, compliance abdominal dynamic per liter and PIA max;Surgeon experience in laparoscopic surgery, cases annually, years of experience, previous experience with low IAP, Duration of surgery; Basic features of airway pressures (plateauP, peakP, pulmonary Compliance); Spontaneous / coughing movements during surgery and recruitment maneuvers; Postoperative pain in the first 24 hours (area under VAS , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/limphocite ratio, C-reactive protein, interleukin-6 and procalcitonin) in the day 1 and 3 of postoperative; Selected complications are evaluated using the scale of Clavier-Dindo; inpatient days. |
PIA durante la cirugía en el grupo individualizado; Pv0, compliance abdominal dinámica por cada litro y PIA max; Experiencia del cirujano en cirugía laparoscópica; casos anuales; años de experiencia; experiencia previa con PIA bajas; Duración de la cirugía; Características básicas de las presiones en vía aérea (Pplateau, Ppico, Compliance pulmonar); Movimientos espontáneos/tos durante la cirugía y maniobras de reclutamiento; Evaluación del dolor postoperatorio en las primeras 24h (área de EVA bajo la curva, opiáceos de rescate, dolor referido al hombro); Marcadores inflamatorios y de stress quirúrgico(cociente neutrófilos/linfocitos, proteína C reactiva, interleukina-6, procalcitonina, creatinina)en los días 1 y 3 del postoperatorio; complicaciones postoperatorias mediante la clasificación de Clavier-Dindo; Días de estancia hospitalaria. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years, classification of the American Society of Anesthesiologists (ASA I-III), no cognitive deficits, signed informed consent prior to surgery. |
Pacientes mayores de 18 años, Clasificación de la American Society of Anesthesiologists (ASA I-III), no déficit cognitivo, consentimiento informado firmado previo. |
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E.4 | Principal exclusion criteria |
Emergency surgery, pregnancy or lactation, immune disorders, kidney or liver disease or advanced-stage cardiopulmonary Patient refusal to participate in the study, patients under 18 years or inability to consent, associated neuromuscular disorders, contraindication for the use of rocuronium / sugammadex, Allergy or hypersensitivity to rocuronium / sugammadex |
Cirugía urgente, embarazo o lactancia, trastorno inmunológico, enfermedad renal o hepática o cardiopulmonar en estadio avanzado Negativa del paciente a participar en el estudio, Pacientes menores de 18 años o con incapacidad para dar su consentimiento, trastornos neuromusculares asociados, contraindicación para el uso de rocuronio/sugammadex, Alergia o hipersensibilidad conocida a Rocuronio/sugammadex |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quality validated scale of postoperative recovery (PQRS- Postoperative Quality of Recovery Scale) within 15 minutes (T15) and 40 minutes (T40) of their stay in the Post-Anaesthesia Recovery Unit and the day 1 (POD1) and day 3 (POD3) of the postoperative (POD- Postoperative Day) |
Escala de calidad recuperación postoperatoria (PQRS- Postoperative Quality of Recovery Scale) a los 15 minutos (T15) y a los 40 minutos(T40) de su estancia en la Unidad de Recuperación postanestésica y el día 1(POD1) y dia 3 (POD3) del postoperatorio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The variables are collected in a standardized case report form data. PQRS is conduct baseline and after admission to PACU (postanesthesia care unit) at 15 minutes (T15) and 40 minutes (T40) and postoperatively on day 1 (POD1) and day 3 (POD3). Analytical determinations with inflammatory markers and surgical stress are performed during postoperative day 1 (POD1) and day 3 (POD3). |
Se realizará una medición basal el día de la cirugía y tras la cirugía se repetirá la escala a los 15 minutos (T15) y a los 40 minutos (T40) de su estancia en la Unidad de Recuperación postanestésica y el día 1 del postoperatorio (POD1) y dia 3 (POD3) del postoperatorio. |
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E.5.2 | Secondary end point(s) |
Patients characteristics; IAP during surgery in the individualized grup; PV0, compliance abdominal dynamic per liter and PIA max; Surgeon experience in laparoscopic surgery, cases annually, years of experience, previous experience with low IAP, Duration of surgery; Basic features of airway pressures (plateauP, peakP, pulmonary Compliance); Spontaneous / coughing movements during surgery and recruitment maneuvers; Postoperative pain in the first 24 hours (area under VAS , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/limphocite ratio, C-reactive protein, interleukin-6 and procalcitonin) in the day 1 and 3 of postoperative; Selected complications are evaluated using the scale of Clavier-Dindo; inpatient days. |
Características de los pacientes. Pv0, compliance abdominal dinámica por cada litro y PIA max. Experiencia del cirujano en cirugía laparoscópica, casos anuales, años de experiencia, experiencia previa con PIA bajas. Duración de la cirugía Características básicas de las presiones en vía aérea. (Pplateau, Ppico, Compliance pulmonar antes de la generación del pneumoperitoneo y tras la generación del mismo con PIA estable y tras maniobras de reclutamiento). Movimientos espontáneos/tos durante la cirugía y maniobras de reclutamiento. Dolor postoperatorio en las primeras 24h (área de EVA bajo la curva, opiáceos de rescate, dolor referido al hombro). Marcadores inflamatorios y de stress quirúrgico (cociente neutrófilos/linfocitos, proteína C reactiva, interleukina-6, procalcitonina, creatinina) en los días 1 y 3 del postoperatorio. Se registrarán las complicaciones postoperatorias mediante la clasificación de Clavier-Dindo (náuseas/vómitos, íleo paralítico, dehiscencia de sutura, infección de la herida quirúrgica, sepsis, hemorragia, hipoxemia, atelectasias, neumonía, derrame pleural, fracaso renal ). Estancia hospitalaria. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Variables are collected during surgery, in immediate postoperative and during the days 1 and 3, monitoring complications to hospital discharge. |
Se recogerán datos durante la cirugía, en el postoperatorio inmediato y durante los días 1 y 3 realizándose seguimiento de las complicaciones hasta el alta hospitalaria. |
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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) | 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 | 5 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |