Multimodal (multistage) prehabilitation for major surgical procedures in older patients to reduce complication rates and costs: A randomized, prospective, monocentric, multidisciplinary study (PREHABIL study).
Descrizione riassuntiva dello studio
Participants will be randomly assigned to one of two groups. In the first group, the control group, preparation is done according to the usual method in the treating clinic (orthopedics, urology, abdominal surgery, etc.). In the second group, the intervention group, a multistage preparation is conducted. This consists of an individually tailored package of physical exercise under physiotherapeutic guidance, preventive treatment of any potential anemia, correction of malnutrition, and support for smoking cessation. With your consent, the treating surgeon will refer you to us. First, a series of examinations (strength and endurance tests, blood analyses) will be conducted, as well as some questionnaires to be filled out. If you are assigned to the intervention group, we will then begin the aforementioned preparations over a period of two to four weeks. If you belong to the control group, this step will be omitted. The day before the surgery, this examination will be repeated to assess the effect of the interventions. Four weeks after the surgery, you will receive questionnaires from us again. Your time commitment may vary significantly depending on group assignment. For the control group, we estimate a commitment of about 8 hours, spread over 3 to 4 hospital visits. For the intervention group, at least two additional hospital visits for training guidance of one hour each, along with the time commitment for home training (5x30min/week) and possibly consultations in the clinic for nutritional counseling (30min each) will be added. We try to minimize your commitment by combining visits to the various clinics (operating clinic, anesthesia, physiotherapy, nutritional counseling) whenever possible.
(BASEC)
Intervento studiato
Multimodal pre-habilitation: physical activity, anemia (low blood count) correction, diet optimization and smoking cessation.
(BASEC)
Malattie studiate
The study examines whether it is possible to positively influence recovery after surgery with multimodal (multi-stage) preparation of the patient. We hope to prevent possible complications and ultimately reduce the follow-up costs of the intervention.
(BASEC)
You are about to have a major surgical procedure, are over 65 years old and have a combination of pre-existing conditions (e.g. diabetes, obesity or smoker's lungs) that may increase the risk for the surgical procedure. (BASEC)
Criteri di esclusione
Illnesses or infirmities that make it impossible to participate in physical exercise (cognition, paralysis, severe pain). Regular blood washing in kidney failure. Palliative or emergency surgeries. (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
not applicable
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dominique Engel
0041316320134
dominique.engel@clutterinsel.chDepartment of Anaesthesiology and Pain Therapy Inselspital, Bern University Hospital Freiburgstrasse 3010 Bern
(BASEC)
Informazioni generali
Department of Anaesthesiology and Pain Therapy, University Hospital Bern,
0041316322111;00316322111
dominique.engel@clutterinsel.ch(ICTRP)
Informazioni scientifiche
Department of Anaesthesiology and Pain Therapy, University Hospital Bern,
0041316322111;00316322111
dominique.engel@clutterinsel.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
13.07.2021
(BASEC)
ID di studio ICTRP
NCT04461301 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Multimodal prehabilitation for major surgery in elderly patients to lower complications: A randomised, prospective, multi-centre, multidisciplinary trial (PREHABIL Trial). (BASEC)
Titolo accademico
Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial). (ICTRP)
Titolo pubblico
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (ICTRP)
Malattie studiate
Frail Elderly Syndrome;Major Surgery (ICTRP)
Intervento studiato
Procedure: Multimodal Prehabilitation (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 65 Years
Inclusion Criteria:
- Written informed consent
- comorbid (=ASA 3)
- pre-existing fitness deficit: AT<11ml/kg/min respectively VO2peak<14ml/kg/min if AT
unavailable or VE/VCO2 slope > 33
- scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular
surgery
- screening at least 2 weeks prior to surgery
Exclusion Criteria:
- Paralysis or patients with mobility problems (who are unable to exercise),
- Premorbid conditions or orthopaedic impairments that contraindicate exercise,
- Cognitive disabilities,
- Chronic renal failure (need for dialysis)
- Emergency procedures. (ICTRP)
non disponibile
Endpoint primari e secondari
Comprehensive Complication Index (CCI) (ICTRP)
Cardiovascular & Pulmonary;Nutrition & Bioimpendance;Anaemia;Smoking;Questionnaires for recovery, anxiety and cardiac risk (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Bern;Department of clinical research, Bern (ICTRP)
Contatti aggiuntivi
Dominique A Engel, Dr;Dominique A Engel, Dr;Dominique A Engel, Dr, dominique.engel@insel.ch, 0041316322111;00316322111, Department of Anaesthesiology and Pain Therapy, University Hospital Bern, (ICTRP)
ID secondari
PREHAB2020 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04461301 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile