Project Status

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Chief Investigators

César Aldecoa. Spanish Perioperative Audit and Research Network. REDGERM. Río Ortega University Hospital, Valladolid, Spain

Carlos Ferrando Ortolà. Spanish Perioperative Audit and Research Network. REDGERM. Hospital Clinic de Barcelona, Spain

Study Funders

This study is endorsed by the Spanish Multimodal Rehabilitation Group (GERM), the Spanish Perwioperative Audit and Research Network (REDGERM), and the Spanish Society of Anesthesiology (SEDAR)

Aims of the Study

1. To identify the prevalence and severity of frailty in patients undergoing elective as well as urgent surgeries.
2. To identify whether the application of perioperative prehabilitation programs is associated with an improvement in the frailty state and in the clinical outcomes 30 days after surgery.
3. To identify postoperative complications in frail patients both at a national level and an international level.
4. To identify the differences in postoperative quality of life 30 days after surgery between frail and non-frail patients, and between the different degrees of frailty after urgent and elective surgery.
5. Overall, a high international participation is anticipated. Therefore, the obtained data will allow not only to clearly define the prevalence of frailty in different age groups, in different types of surgery and in urgent or elective surgery, but also to identify which are the key elements to patients’ recovery of a prehabilitation or posthabilitation program as well as to establish which patients could benefit most of the aforementioned programs. Additionally, it will identify those areas of knowledge that need further study.

Endpoints

Primary outcome measure
To evaluate the prevalence and degree of frailty in a population of patients undergoing programmed or emergency surgical interventions that require hospital admission.
Secondary outcome measures
Secondary objectives

6. To evaluate global frailty prevalence by age groups.
7. To evaluate the association between the presence and degree of frailty, and postoperative complications, hospital stay and 30-day mortality.
8. To describe the relationship between the degree of frailty and quality of life 30 days after surgery.
9. To describe the association between frailty and postoperative cognitive disorder and delirium by age groups.
10. To evaluate if the routine implementation of a preoperative prehabilitation program in the subgroup of patients programmed for surgery and its relationship with frailty and postoperative outcomes.
11. To evaluate the routine implementation of early rehabilitation measures in surgical patients and its relationship with frailty and postoperative outcomes.
12. To describe the relationship between each predefined item of prehabilitation and postoperative rehabilitation with clinical outcomes, including complications, hospital stay and quality of life at 30 days.

What will happen in this study (methods)?

European prospective one day cohort study. Analysis of the prevalence of frailtyand predefined 30-day postoperative complications in adult patients undergoing emergency orelective surgery.

Investigation sites: European hospitals where elective or emergency surgery is performed,where preoperative frailty index can be determined and patients can be followed for 30 days.

Who can participate and how will they benefit from taking part?

All the European centers are invited to participate. All collaborators will be recognized as collaborators in all publications derived from FRAGILE. There is no economic compensation.

What are the next steps for potential participants?

Participating sites should contact with the National Coordinators or suscribe interest in this website.
For access to the online database platform we will need the name of the principal investigator and his email and the name of the center

What is the timescale?

FRAGILE starts in Spring 2020 The day of recruitment in each center can be selected within a period in spring 2020.

How will the results be disseminated?

The study will be published in indexed peer reviewed journals.

Mauricio Cecconi

Department Anaesthesia and Intensive Care Units IRCCS Istituto Clinico Humanitas Milan, Italy.

  Antonio Spinelli

IRCCS Istituto Clinico Humanitas, Milan, Italy.

Gianluca Pellino

ItSurg

Francesco Plata

ItSurg

  Nádia Tenreiro

Centro Hospitalar de Trás-os-Montes e Alto Douro

Georgion Maria

Nicosia General Hospital. Cyprus

Başak Ceyda

Department of Anaesthesiology and ICM. Ibn Sina University Hospital, Ankara, Turkey.

Rupert Pearse

Intensive Care Medicine Queen Mary University London London, UK

Michelle Chew

Institutionen för medicin och hälsa (IMH)

Radmilo Jancovick

Ionut Negoi

General Surgery Department. Emergency Hospital of Bucharest, Romania.

Michelle Chew

Institutionen för medicin och hälsa (IMH)

Peter Paal

Anaesthesiology and Intensive Care Medicine. Krankenhaus der Barmherzigen Brüder Salzburg. Vienna.

Barbara Mrázová

F.D. Roosevelt University Hospital. Slovakia.

Javier Ripollés Melchor

Hospital Universitario Infanta Leonor, Madrid

Claudia Spies

Director Department of Anesthesiology, Division of Operative Intensive Care Medicine; Charité, Berlin

Marc Leone

Intensive Care Medicine, Respiratory Medicine, General Internal Medicine Institute: Aix Marseille University, North Hospital, Assistance Publique – Hôpitaux de Marseille

Ioannidis Orestis

Fourth Surgical Department, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Seppe Koopman

Anesthesiologist. Maasstad Hospital. Rotterdam, The Netherlands