Cardiovascular Diseases, Gastrointestinal Disease, Orthopedic Disorder, Thoracic Diseases, Urologic Diseases
Conditions
Brief summary
Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery
Detailed description
Prehabilitation programs essentially based on physical activity improvement may reduce postoperative complications after major surgery. We hypothesize that a multimodal program based on physical activity, nutritional support and mental preparation may not only improve postoperative recovery and reduce costs but also improve health status beyond postoperative period. Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery. Other outcomes will be measured : length of hospital stay, hospital readmissions, direct costs, health status at 1 and 6 months. Moreover, the feasibility and adherence of Paprika program will be evaluated. Inter-data centres relating to the implementation of the same prehabilitation program will be compared with the consortium Paprika (Hospital Clinic of Barcelona, University of Cologne, University of Gdansk)
Interventions
OTHERmultimodal prehabilitation
Paprika prehabilitation program content: patients will have choices for each activity. Messages and motivation will be reinforced by using a mobile app or leaflet advices, according to patient's preferences. * Physical activity promotion by discovering ebike, personalised gymnastics and encouragement to increase the number of daily steps of patients, measured by a wristband and a mobile App * An individualized nutritional optimization plan with dietary advices and protein supplementation (if necessary). * Psychological support will be proposed through auto-hypnosis sensibilisation or management of stress with Cognitive Behavior Stress Management technics
Sponsors
EIT Health
Hospital Clinic of Barcelona
Universitätsklinikum Köln
University Clinical Centre, Gdansk
University Hospital, Grenoble
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Paprika program will be proposed to all eligible patients.
Intervention model description
Interventional group: Patients with Paprika program Historical group: Patients with same characteristics operated in 2018-2019
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient eligible to elective major surgery (digestive, orthopedic, vascular-thoracic, urologic) * Age \> 70 years and/or American Society of Anesthesiologists (ASA) score 3-4 * or Unfit patient according to appropriate scores (Two among 3 scores (HAD, Physical activity score, nutritional score) below threshold). Unfit patients will be defined by at least 2 criteria if 'YES' answers: Physical activity: Less than 50% of WHO recommendations = less than 5000 steps/day or less than 75 min moderate activity/week or less than 12 min moderate activity/day Yes/No Malnutrition: BMI \< 20 kg/m2 if \< 70 years (or \<22 if \>70y) = undernutrition Yes/No or BMI\>25 kg/m2 (= overweight to obesity) or Loss of appetite? Mental evaluation HAD (Hospital Anxiety and Depression) \>8 for A or D score Yes/No * Diagnosis: Elective major surgery (digestive, orthopedic, vascular-thoracic, urologic) \- Regulatory aspects: Be legally able to give consent Patient affiliated to social security
Exclusion criteria
* Planned surgery (less than 4 weeks at inclusion) * Urgent surgery * Patient with, at baseline, good to excellent physical, nutritional, mental status as defined by appropriate scores. * Patient considered not eligible to this program for physical or psychological reasons by the surgeon or the anesthetist * Persons referred in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative complications at Day-30 | at Day-30 post surgery | Rate of postoperative complications at Day-30 classified following the standards of the European Society of Anaesthesiology and European Society of intensive Care Medicine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay (ICU and Hospital) | within 30 days post surgery | Length of ICU stay and Length of hospital stay |
| Hospital readmission | within 30 days post surgery | Hospital readmission within 30 days |
| Direct cost | interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery | Valuation in euros of the direct cost from a 1-month hospital point of view (duration and type of stay, acts, GHM...) by integrating for the intervention group the cost of the pre-habilitation program. Care consumption at 6 months from a social security perspective (Probabilistic Matching National Health Data System)--\> comparison of direct costs for the Prehab sessions (professional caregivers and materials costs) versus complication costs of control group |
| Physical activity health status | a baseline, presurgery and 6 months post surgery | Health status based on physical activity score:GPAQ and DASI scores |
| Number and severity of postoperative complications | within 30 days post surgery | Number and severity of postoperative complications using Dindo-Clavien classification within 30 days |
| Psychological health status | at baseline, 1 month and 6 months | Psychological health status based on HAD, Perceived Stress Scale scores |
| Number of patient participation to program in relation to the number of eligible patients | During Paprika inclusion period | Number of patient participation to program in relation to the number of eligible patients to assess faisability |
| Ratio patient participation to each session | During Paprika 1 month-sessions | Ratio patient participation to each session to assess faisability and limitation to participation |
| Comparison with other centers | through study completion, an average of 1 year | Comparison will be done with other cohorts using Paprika program (Barcelona, Gdansk and Köln) on common outcomes |
| Nutritional health status | at baseline, 1 month and 6 months | Nutritional health status based on weight, appetite and ingesta measurements |
Countries
France
Contacts
Primary ContactMarie-France Vaillant
Backup ContactLaura Albaladejo
Outcome results
None listed