E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
partial laparoscopic nephrectomy |
nefrectomías parciales laparoscópicas |
|
E.1.1.1 | Medical condition in easily understood language |
partial kidney removal by laparoscopy |
extracción parcial renal por vía laparoscópica |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047691 |
E.1.2 | Term | Volume depletion |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034072 |
E.1.2 | Term | Partial nephrectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 |
Assess wether there are differences in the glomerular filtration rate 6 months after laparoscopic partial nephrectomy according administered fluid therapy |
Evaluar si existen diferencias en el filtrado glomerular a los 6 meses posteriores a una nefrectomia parcial laparoscópica según la fluidoterapia administrada |
|
E.2.2 | Secondary objectives of the trial |
study wether there are differences among 3 arms in: diuresis during the first postoperative 24 hours; central venous pressure during the first postoperative 24 hours; intraocular pressure during surgical procedure; Blood pressure changes during surgical procedure and in the postoperative period; Postoperative nausea and vomiting incidence; bleeding during surgical procedure and in the postoperative period; possible complications. |
Estudiar si existen diferencias entre los 3 grupos en: la diuresis durante las primeras 24 horas postoperatorias la presión venosa central (PVC) durante las primeras 24 horas postoperatorias la presión introcular (PIO) durante el intraoperatorio Modificaciones de la presión arterial (PANI) durante el intra y postoperatorio náuseas y vómitos postoperatorios el sangrado quirúrgico y postquirúrgico posibles complicaciones |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18; Patients undergoing a partial laparoscopic nephrectomy; Preoperative ASA ? III` Preoperative and intraoperative anaesthesia according to clinical practice Surgical procedure without complications Previous informed consent of patients |
- Mayores de 18 años. - Pacientes sometidos a Nefrectomía parcial laparoscópica - Valoración del estado físico preoperatorio ASA ? III - Anestesia prequirúrgica e intraquirúrgica según práctica habitual - Intervención quirúrgica sin complicaciones. - Paciente que haya aceptado participar en el estudio y haya firmado el consentimiento informado preintervención quirúrgica |
|
E.4 | Principal exclusion criteria |
Pregnancy or Breastfeeding Obesity or overweight, BMI >= 20% regarding ideal GF < 60ml/min Severe coronary desease (NYHA class. III and IV) Allergy to drugs used during anaesthesia |
- Embarazo o lactancia - Obesidad o sobrepeso. IMC >= 20 % superior al ideal. - FG < 60ml/min - Enfermedad coronaria severa (NYHA clase III y IV) - Alergia a los fármacos que se utilizan durante la anestesia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Glomerular filtration rate at 6 months |
Filtrado glomerular a los 6 meses |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
diuresis during first 24 hours central venous pressure during first 24 hours intraocular pressure blood pressure changes nausea and vomiting Bleeding Complications |
diuresis durante las primeras 24 horas presión venosa central (PVC) durante las primeras 24 horas presión intraocular (PIO) - Modificaciones de la presión arterial (PANI) - náuseas y vómitos - Sangrado - Complicaciones |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the procedure, postoperative period and at 6 months |
Durante la intervención, en el periodo postoperatorio y a los 6 meses |
|
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 | No |
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 | 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 | No |
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 |
no tratamiento |
no treatment |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 visit of last patient included |
última visita del último paciente incluido |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |