Patient Empowerment for Major Surgery Preparation @ Home (Paprika)

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Orthopedic Disorder

Gastrointestinal Disease

Thoracic Diseases

Cardiovascular Diseases

Urologic Diseases

Treatments

Other: multimodal prehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04190719

38RC19.182

Details and patient eligibility

About

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

Full 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)

Enrollment

225 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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).