Clinical trial NCT04750876: Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients
Official title: Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: An amputation represents a real ordeal for the person who will have to overcome the loss of a limb and face long months of rehabilitation. It is most often carried out following arterial insufficiency.

As paramedical professionals, we see in our daily practice a physical and psychological suffering for amputee patients. In spite of our skills acquired through training and professional experience, we are unable to offer comprehensive care for these patients and therefore feel that we are offering incomplete care. A multidisciplinary care, including a medical and paramedical team, would seem to us to be more appropriate for patients with lower limb amputations.

Following this observation, we would like to highlight the interest for the patient and the care team to include a psychologist and a physiotherapist in the care offer to evaluate the improvement of the physical and emotional state of the amputee patient.


Eligibility criteria: Inclusion Criteria:

* Patient over the age of majority, no age limit
* Amputation related to obliterative arteriopathy of the lower limbs
* Trans-tibial or trans-femoral amputation in an already amputated patient
* Patient with an indication of discharge to a rehabilitation and re-education service
* Patient with the ability to understand the protocol
* Patient who has agreed to participate in the study and has given express oral consent
* Patient receiving social security cover or entitled to it

Exclusion Criteria:

* Trauma related amputation
* Patient with no history of amputation
* Amputation of upper limb, trans-metatarsal or one or more toes
* Amputation of comfort in a palliative care setting
* Patient leaving home after surgery
* Patient undergoing psychological or psychiatric treatment
* Pregnant or breastfeeding woman, or a woman who is able to procreate without effective contraception
* Patient unable to follow the protocol as judged by the investigator
* Patient participating in another interventional research protocol involving a drug or medical device
* Patient under guardianship, curators or legal protection measure

Primary outcomes:
measure: To evaluate the relevance of the intervention of a physical therapist and a psychologist in the management of amputee patients in vascular surgery at 10 days post-operatively.
timeFrame: at 10 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche Sur Yon
country: France
facility: Departmental Hospital Centre - Vendee
Study officials:
affiliation: Departmental Hospital Centre - Vendee
name: Nathalie CORDON
role: PRINCIPAL_INVESTIGATOR
References: