Multimodal (multistage) prehabilitation for major surgical procedures in older patients to reduce complication rates and costs: A randomized, prospective, monocentric, multidisciplinary study (PREHABIL study).
Résumé de l'étude
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)
Intervention étudiée
Multimodal pre-habilitation: physical activity, anemia (low blood count) correction, diet optimization and smoking cessation.
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Berne
(BASEC)
Sponsor
not applicable
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dominique Engel
0041316320134
dominique.engel@clutterinsel.chDepartment of Anaesthesiology and Pain Therapy Inselspital, Bern University Hospital Freiburgstrasse 3010 Bern
(BASEC)
Informations générales
Department of Anaesthesiology and Pain Therapy, University Hospital Bern,
0041316322111;00316322111
dominique.engel@clutterinsel.ch(ICTRP)
Informations scientifiques
Department of Anaesthesiology and Pain Therapy, University Hospital Bern,
0041316322111;00316322111
dominique.engel@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
13.07.2021
(BASEC)
Identifiant de l'essai ICTRP
NCT04461301 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Multimodal prehabilitation for major surgery in elderly patients to lower complications: A randomised, prospective, multi-centre, multidisciplinary trial (PREHABIL Trial). (BASEC)
Titre académique
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)
Titre public
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (ICTRP)
Maladie en cours d'investigation
Frail Elderly Syndrome;Major Surgery (ICTRP)
Intervention étudiée
Procedure: Multimodal Prehabilitation (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Comprehensive Complication Index (CCI) (ICTRP)
Cardiovascular & Pulmonary;Nutrition & Bioimpendance;Anaemia;Smoking;Questionnaires for recovery, anxiety and cardiac risk (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University of Bern;Department of clinical research, Bern (ICTRP)
Contacts supplémentaires
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 secondaires
PREHAB2020 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04461301 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible