Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Pre-operative Interventional Paramedical Consultation: What About the Implantable Device? (COPAIN)

4 de mayo de 2026 actualizado por: University Hospital, Grenoble

The placement of implantable ports is carried out at CHUGA by several departments, including the Interventional Radiology Department.

The radiology team places between 350 and 370 implantable ports each year (figures for 2023: 361, 2024: 363).

It is a short procedure (less than an hour), carried out under local anaesthetic. Following this, the interventional radiologist makes two incisions: one at the base of the neck and the second beneath the collarbone on the same side. The olive-sized housing is positioned at the incision near the collarbone. The catheter is connected to the device and then enters the neck vein at the second incision after travelling under the skin. The two incisions are closed with a few stitches, still under local anaesthetic. After the procedure, the patient gets dressed and can go home with a prescription for nursing care. Due to a lack of available medical time, there is currently no pre-procedural consultation carried out by radiologists prior to this procedure. The information is therefore provided by the oncologist during the oncology consultation, alongside a wealth of other information regarding the oncological condition. When an appointment is made through the interventional radiology department's reception, a standardised written information sheet is sent to the patient along with the appointment letters. The MERM team in the interventional radiology department observed that information regarding the procedure's conduct almost invariably had to be repeated when the patient was admitted to the procedure suite. According to an internal department assessment conducted over one month, the investigators found that of 31 patients attending for the insertion of an implantable port, 11 patients (35.5%) were highly anxious, 9 patients (29%) had received no information at all regarding the procedure, and only 8 patients (25.8%) were not anxious and felt they had been properly informed. Furthermore, 4 patients (12.9%) did not undergo the procedure due to a major error in the management of anticoagulants, and 7 patients (22.5%) had not undergone the preoperative blood tests normally recommended.

During the pre-procedure consultation, which lasts approximately 30 minutes, you will be given full details of the examination process, from settling in the procedure room right through to the dressing. Pre- and post-operative instructions will also be provided, along with the relevant prescriptions (discontinuation of anticoagulants, Betadine shower, referral for a blood test to be carried out in the laboratory beforehand, dressings and a follow-up visit from a private nurse afterwards). The issue of transport to and from the hospital on the day of the procedure (arrangements, transport vouchers) will also be discussed. This time will be used to introduce the patient to the department and the healthcare staff who will be looking after them, using visual aids (photographs), as well as to show them a device identical to the one that will be implanted, if they wish.

Unlike the information currently provided on the day of the examination, this consultation will take place in a confidential and calm setting where the patient will also be able to ask any questions they may have.

Assessing patients' anxiety preoperatively is not easy, but the most widely validated scale is the State and Trait Anxiety Index (STAI) (1), which has been translated into French but comprises 20 items and is therefore cumbersome to administer.

The Visual Analogue Scale (VAS) is much easier to use in practice and began to be used in the context of anxiety in the 1970s (2) A prospective study (3) conducted at Poitiers University Hospital demonstrated a good correlation between the STAI scale and the Visual Analogue Scale (VAS) upon entering the operating theatre. A randomised study of 89 patients conducted at Limoges University Hospital showed that an information consultation held approximately 7 days before gastrointestinal surgery reduced patients' anxiety as assessed by the VAS-Anxiety (VAS-A) score (4).

The investigators therefore hypothesise that an information consultation conducted by a MERM would help to reduce anxiety in patients coming to our department for the placement of an implantable port in an oncological context

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

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.

Ubicaciones de estudio

      • Grenoble, Francia, 38043
        • University Hospital Grenoble
        • Contacto:
        • Contacto:

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

No

Descripción

Inclusion Criteria:

  • Patients scheduled to have an implantable port fitted in the Radiology Department at CHUGA
  • Patients aged 18 or over

Exclusion Criteria:

  • Patients with a history of implantable port placement
  • Implantable port placement for a non-oncological indication
  • Emergency implantable port placement that could increase the patient's anxiety (port placement scheduled as an emergency within 7 days of the oncology consultation)
  • Subject currently excluded from another study
  • Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (i.e. all protected persons: pregnant women, women in labour, breastfeeding mothers, persons deprived of their liberty by judicial or administrative order, and persons subject to a legal protection measure)

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

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Paramedical consultation
Addition of a specific paramedical consultation lasting conducted by a MERM, prior to the procedure .
Addition of a dedicated paramedical consultation lasting approximately 30 minutes, conducted by a MERM, prior to the procedure
Sin intervención: Standard coverage
Standard care (information provided by the oncologist + standardised written form).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient's anxiety during pre-implantation paramedical consultation and patient's anxiety without paramedical consultation as Assessed by EVA-A Scores on the Visual Analog Scale at Day 0 before the procedure).
Periodo de tiempo: Day 0 - Before the procedure
Comparison of the EVA-A score (The Visual Analogue Scale is a scale used to assess anxiety. Here, we will measures the intensity of patient's anxiety on a scale of 0 who is the worthess to 10 who is the best.) at the time the patient is welcomed into the changing room between the group of patients receiving standard care in the radiology department (information provided during the oncology consultation + information sheet) and the group of patients receiving an additional paramedical information consultation.
Day 0 - Before the procedure

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Impact of a pre-implantation paramedical consultation on the number of incidents preventing the implantation of an implantable port (management of anticoagulants/antiplatelet agents, blood samples taken by the patient).
Periodo de tiempo: Day 0 - Before the procedure
Comparison of the number of patients for whom there was an error in the advice given at the time of booking the appointment (management of anticoagulants/antiplatelet agents and blood tests) in accordance with CIRSE guidelines (5) prior to the insertion of an implantable port between the two groups.
Day 0 - Before the procedure
Impact of a pre-operative paramedical consultation prior to the implantation of an implantable port on the time taken to admit the patient on the day of the procedure.
Periodo de tiempo: Day 0 - Before the procedure
Comparison of the average waiting time (in minutes) between the two groups, from the moment the patient is admitted to the waiting room until the moment they are ready to enter the operating theatre to begin the procedure.
Day 0 - Before the procedure
Patients' views on the value of a pre-operative consultation with a healthcare professional prior to the implantation of a pacemaker, in terms of their understanding of the upcoming procedure.
Periodo de tiempo: Day-10 after paramedical consultation (only for interventional arm)
Assessment of overall patient satisfaction following the consultation, measured using a 5-point Likert scale. (The Likert scale is a psychometric tool used to measure individuals' attitudes, opinions or perceptions through a series of responses on a scale ranging from agreement to disagreement. Here we have 5 points, 0 is the worthess = disagreement, 5 is the best = agreement.
Day-10 after paramedical consultation (only for interventional arm)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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.

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 septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2029

Finalización del estudio (Estimado)

1 de noviembre de 2029

Fechas de registro del estudio

Enviado por primera vez

23 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 38RC25.0303
  • 2026-A00869-42 (Otro identificador: ID RCB)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

Suscribir