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Multimodal prehabilitation for major surgery in elderly patients to lower complications and to increase cost effectiveness. A randomized, prospective, multicenter, multidisciplinary trial (PREHABIL trial).

English title Multimodal prehabilitation for major surgery in elderly patients to lower complications and to increase cost effectiveness. A randomized, prospective, multicenter, multidisciplinary trial (PREHABIL trial).
Applicant Wüthrich Patrick
Number 201298
Funding scheme Investigator Initiated Clinical Trials (IICT)
Research institution Universitätsklinik für Anästhesiologie und Schmerztherapie Inselspital
Institution of higher education University of Berne - BE
Main discipline Surgery
Start/End 01.07.2021 - 28.02.2025
Approved amount 1'058'618.00
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All Disciplines (4)

Discipline
Surgery
Geriatrics
Clinical Nutritional Research
Clinical Cardiovascular Research

Keywords (5)

prehabilitation; postoperative complication; major surgery; outcome; old patient

Lay Summary (German)

Lead
Viele Patienten leiden nach geplanten Operationen an Komplikationen. Obschon sich die perioperative Medizin seit Jahren stetig verbessert, bleibt die Wahrscheinlichkeit einer Komplikation nach einem grossen chirurgischen Eingriff, vor allem bei älteren, gebrechlichen Patienten bei 30 -50%. Multimodale Prähabilitationsprogramme zielen darauf ab, den Patienten ab dem Entscheid zur Operation bis zum Wiedererlangen seiner vollen funktionellen Fähigkeiten optimal zu begleiten und zu unterstützen und damit die Komplikationsrate und Hospitalisationsdauer zu senken.
Lay summary

Seit der Einführung von Programmen wie ERAS (verbesserte Erholung nach stattgefundener Chirurgie) haben unzählige Studien dessen positiven Einfluss bestätigt. Verglichen mit traditioneller Pflege sind Patienten welche ERAS-Programme durchlaufen weniger lange im Spital, leiden unter weniger Komplikationen und berichten über bessere Erfahrung.

Weiter ist bekannt, dass eine schlechte physische Ausgangslage mit einem schlechteren Ergebnis nach Operationen vergesellschaftet ist. Viele Patienten leiden noch Monate nach einem chirurgischen Eingriff an körperlichen Einschränkungen. Das Ziel der perioperativen Medizin ist es, einen möglichst Patienten-orientierten Weg zu erarbeiten, in welchem die Versorgung auf jeden einzelnen Patienten und dessen Bedürfnisse zugeschnitten sind und bis zur vollständigen Erholung andauern.

Das Konzept der Prähabilitation zielt darauf ab, spezifische Beeinträchtigungen eines Patienten zu erkennen und diese mittels gezielter Eingriffe in der präoperativen Phase zu verbessern. Möglich ist die Verbesserung der physischen Ausgangslage (Kraft, Kondition und Ernährung), psychologische Stärkung durch Stressreduktion, Korrektur einer möglichen Blutarmut, sowie die Vermeidung von schädlichen Einflüssen (Nikotin und Alkohol).

Das Ziel unserer Studie ist es herauszufinden, ob ein multimodales Prähabilitationsprogramm während 2-4 Wochen, im Stande ist die Komplikationsrate positiv zu beeinflussen.

Direct link to Lay Summary Last update: 13.07.2021

Responsible applicant and co-applicants

Employees

Project partner

Collaboration

Group / person Country
Types of collaboration
Franco Carli and Chelsia Gillis McGill University/Montreal University Health Center, Montre Canada (North America)
- in-depth/constructive exchanges on approaches, methods or results

Abstract

Background:Postoperative complication rate is up to 50% in patients undergoing major surgery. One found a 20-40% reduction in physiological and functional capacity after major surgery. In the future a major proportion of patients presenting for surgery will be older than 65 years. Elderly patients have more postoperative complications and longer convalescence. The incidence and severity of complications are closely related to preoperative functional capacity, nutritional state, and smoking behavior. In times of increasingly complex medical needs, economic issues and surgery on old population, it is of crucial importance to optimize patient care before surgery, for which the concept of prehabilitation has emerged.Aims:To investigate the impact of a multimodal prehabilitation on postoperative outcome using the Comprehensive Complication Index (CCI), a validated index (range from 0, no complication, to 100, death) for assessment of multiple postoperative complications.Methodology:This is a national multicentre, multidisciplinary, single-blind, parallel 2 arm (standard of care, n=233) vs prehabilitation, n=233) randomized controlled trial (RCT) with a recruitment period of 3 years.Study populationInclusion criteria: Adult elderly (= 65 years), comorbid (= ASA 3), frail (Fried frailty index =3) patients undergoing major urologic, thoracic, abdominal or vascular surgery.Exclusion criteria: Patients unable to exercise for physiological or psychological reasons, cognitive disabilities, chronic renal failure (dialysis or serum creatinine > 250 µmol/L), emergency and palliative procedures..Participating centresUniversity Hospital of Berne (coordinating hospital), Hospital Tiefenau (Berne)RandomizationPatients will be block randomized with a 1:1 allocation, stratified by study sites, type of surgery and sex. Patients will be allocated either to the intervention group, which will receive 2- 4?weeks of prehabilitation, or to the control group, which will receive standard of care without prehabilitation.Study outline Patients who meet the inclusion criteria and consent to the trial will be scheduled for the baseline visit as soon as possible after the final diagnosis. During the baseline visit, assessments of nutrition and physical fitness status, anemia and smoking are performed and subsequently patients will be randomized to either standard of care or the 2-4-week prehabilitation program. For the prehabilitation patients, an individual treatment strategy will be implemented. The multidisciplinary multimodal prehabilitation program is composed of 4 elements: exercise, nutritional intervention, anemia treatment and smoking cessation.Study outcomesPrimary outcome: Postoperative complications scored by the CCI, calculated using the sum of morbidity and mortality presented on the Clavien Dindo classification, assessed at the 30?days post-surgery follow-up visit. Secondary outcomes will be changes in cardio pulmonary exercise test (CPET), 6 minute walk test (6MWT), timed up and go test (TUG), grip strength, Nutritional Risk Screening score, albumin and prealbumin, haemoglobin, Quality of Recovery score (QoR15), State-Trait Anxiety Inventory (STAI), days at home and well after 30 days (DAH30), smoking habits and time to surgery (i.e. time between decision and intervention).StatisticsSample size calculation: Based on internal data (University Hostpial Bern), median CCI is expected to be 30 (IQR 21 to 37). Assuming an average clinically relevant improvement of 15% in the intervention group compared to the control group, the sample size calculation for a non-parametric Wilcoxon-Mann-Whitney test resulted in a total patient sample of 388 (assuming a significance level alpha of 0.05 and power of 0.85). We expect a dropout rate of 20%. We therefore need 466 patients: 233 in each arm. The difference in CCI between the intervention and the control group will be tested by analysis of covariance (or negative binomial regression in case of zero-inflated distribution) adjusted for center, type of surgery, sex and age.
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