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

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)

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).

Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD

Data will be available at the end of the study: starting July 2021

IPD will be shared with other sites in order to compare results coming from common questionnaires and data. Statistical analyses will be performed for Grenoble site separately and pooled with the other sites in a second step.

Paprika program will be proposed to all eligible patients.