- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07615855
RIDECLAS: Delphi Classification of RICA Pathway Recommendations (RIDECLAS)
22 de mayo de 2026 actualizado por: Jose-M Ramirez, Universidad de Zaragoza
Delphi Study for the Classification of Recommendations for the RICA Pathway (Enhanced Recovery in Adult Surgery)
RIDECLAS is an observational, prospective, non-interventional consensus study using a modified Delphi methodology.
The study aims to obtain expert consensus on the classification and final formulation of recommendations for the RICA Pathway, an enhanced recovery pathway for adult surgery.
Participants will be healthcare professionals with experience in enhanced recovery, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines.
Experts will complete sequential online questionnaires.
Individual responses will remain confidential, and aggregated anonymized feedback will be provided between Delphi rounds.
The study does not involve patients, clinical interventions, biological samples, drugs, or medical devices.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
This study will use a modified Delphi process conducted remotely through electronic questionnaires.
A coordinating committee will prepare an initial list of recommendations based on the previous RICA Pathway document and updated evidence.
Expert panelists will rate each recommendation using a 1-to-9 Likert scale and may provide free-text comments.
Two Delphi rounds are planned, with a third round if needed for items without sufficient consensus or for reformulated statements.
Between rounds, participants will receive aggregated and anonymized feedback, including measures of agreement, median scores, dispersion, and a summary of comments.
Consensus for acceptance is predefined as at least 75% of ratings in the 7-9 range and no more than 15% in the 1-3 range.
Consensus for rejection is predefined as at least 75% of ratings in the 1-3 range and no more than 15% in the 7-9 range.
Items not meeting consensus criteria may be reassessed in subsequent rounds.
The analysis will be descriptive and will include response rates, attrition between rounds, item-level agreement, median scores, interquartile ranges, and qualitative thematic review of comments.
Tipo de estudio
De observación
Inscripción (Estimado)
384
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: José-Manuel Ramírez Rodríguez, Professor of Surgery
- Número de teléfono: +34 976 556400
- Correo electrónico: jramirez@unizar.es
Ubicaciones de estudio
-
-
Zaragoza
-
Zaragoza, Zaragoza, España, 50009
- Department of Surgery
-
Contacto:
- Grupo Español de Rehabilitacion Multimodal GERM SOCIEDAD CIENTIFICA
- Número de teléfono: +34 636935065
- Correo electrónico: secretariagerm@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
The study population will consist of healthcare professionals and scientific society members with experience in enhanced recovery pathways, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines.
Participants will be invited from the Grupo Español de Rehabilitación Multimodal (GERM) and related professional networks.
Descripción
Inclusion Criteria:
- Healthcare professional or researcher with relevant clinical or scientific experience in enhanced recovery pathways, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines.
At least 5 years of professional experience. Membership in GERM or participation in professional networks related to enhanced recovery in adult surgery.
Willingness to participate in the planned Delphi rounds. Provision of electronic informed consent.
Exclusion Criteria:
- Failure to meet the predefined professional experience criteria. Failure to provide informed consent. Failure to complete the first Delphi round. Duplicate or incomplete responses that cannot be validated for analysis.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Expert Panel
Healthcare professionals with experience in enhanced recovery pathways, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines who are invited to participate in the modified Delphi process.
|
Sequential online questionnaires used to rate and classify proposed RICA Pathway recommendations.
This is not a clinical intervention and does not involve patient care, drugs, devices, or invasive procedures.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Expert consensus on RICA Pathway recommendations
Periodo de tiempo: Through study completion, up to 7 months
|
Consensus will be assessed for each recommendation using predefined Delphi criteria.
Acceptance consensus will be defined as at least 75% of ratings in the 7-9 range and no more than 15% in the 1-3 range.
Rejection consensus will be defined as at least 75% of ratings in the 1-3 range and no more than 15% in the 7-9 range.
|
Through study completion, up to 7 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Degree of agreement for each recommendation
Periodo de tiempo: After each Delphi round, up to 7 months.
|
Distribution of ratings, median score, interquartile range, and percentage of ratings in predefined agreement/disagreement ranges.
|
After each Delphi round, up to 7 months.
|
|
Stability of ratings between Delphi rounds
Periodo de tiempo: Between round 1 and round 2, and round 3 if performed, up to 7 months.
|
Descriptive assessment of changes in item-level ratings and consensus status between rounds.
|
Between round 1 and round 2, and round 3 if performed, up to 7 months.
|
|
Response rate and attrition between rounds
Periodo de tiempo: After each Delphi round, up to 7 months.
|
Number and percentage of invited experts who complete each round, and percentage lost between rounds.
|
After each Delphi round, up to 7 months.
|
|
Qualitative analysis of expert comments
Periodo de tiempo: After each Delphi round, up to 7 months.
|
Thematic review of free-text comments to support item reformulation and interpretation of items without consensus.
|
After each Delphi round, up to 7 months.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
- Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan.
- Grupo de trabajo. Vía Clínica de Recuperación Intensificada en Cirugía del Adulto (RICA). Grupo Español de Rehabilitación Multimodal (GERM); 2026. Available at: https://grupogerm.es/via-rica-web/
- Ripolles-Melchor J, Ramirez-Rodriguez JM, Casans-Frances R, Aldecoa C, Abad-Motos A, Logrono-Egea M, Garcia-Erce JA, Camps-Cervantes A, Ferrando-Ortola C, Suarez de la Rica A, Cuellar-Martinez A, Marmana-Mezquita S, Abad-Gurumeta A, Calvo-Vecino JM; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Colorectal Surgery: The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study. JAMA Surg. 2019 Aug 1;154(8):725-736. doi: 10.1001/jamasurg.2019.0995.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- GERMDELPHI
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared.
This is a modified Delphi consensus study involving expert panelists rather than patients.
Individual responses will be treated confidentially, stored in coded form, and analyzed and reported only in aggregate.
Sharing individual-level responses could compromise participant confidentiality and may affect the independence of expert judgment in the Delphi process.
Aggregated results, consensus levels, and methodological details will be reported in the final publication.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .