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

2026년 5월 4일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

연구 유형

중재적

등록 (추정된)

150

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
간섭 없음: Standard coverage
Standard care (information provided by the oncologist + standardised written form).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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).
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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).
기간: 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.
기간: 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.
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2029년 9월 1일

연구 완료 (추정된)

2029년 11월 1일

연구 등록 날짜

최초 제출

2026년 4월 23일

QC 기준을 충족하는 최초 제출

2026년 4월 23일

처음 게시됨 (실제)

2026년 4월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 4일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 38RC25.0303
  • 2026-A00869-42 (기타 식별자: ID RCB)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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