Clinical trial NCT04190719: Patient Empowerment for Major Surgery Preparation @ Home
Official title: Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urologic Diseases
Cardiovascular Diseases
Thoracic Diseases
Orthopedic Disorder
Gastrointestinal Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: EIT Health
name: Hospital Clinic of Barcelona
name: Universitätsklinikum Köln
name: University Clinical Centre, Gdansk
First posted: 2019-12-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional group: Patients with Paprika program Historical group: Patients with same characteristics operated in 2018-2019
Primary purpose: PREVENTION

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)

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of postoperative complications at Day-30
timeFrame: at Day-30 post surgery
Secondary outcomes:
measure: Number and severity of postoperative complications
timeFrame: within 30 days post surgery
measure: Length of stay (ICU and Hospital)
timeFrame: within 30 days post surgery
measure: Hospital readmission
timeFrame: within 30 days post surgery
measure: Direct cost
timeFrame: interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery
measure: Physical activity health status
timeFrame: a baseline, presurgery and 6 months post surgery
measure: Nutritional health status
timeFrame: at baseline, 1 month and 6 months
measure: Psychological health status
timeFrame: at baseline, 1 month and 6 months
measure: Number of patient participation to program in relation to the number of eligible patients
timeFrame: During Paprika inclusion period
measure: Ratio patient participation to each session
timeFrame: During Paprika 1 month-sessions
measure: Comparison with other centers
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Pierre Albaladejo, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
citation: Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25.