Allgemeine Informationen
  • Krankheitskategorie Andere , Chirurgie (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Bern
    (BASEC)
  • Studienverantwortliche Dominique Engel dominique.engel@insel.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 05.05.2025 ICTRP: Import vom 16.11.2024
  • Letzte Aktualisierung 05.05.2025 19:01
HumRes51581 | SNCTP000004541 | BASEC2020-01690 | NCT04461301

Multimodal (multistage) prehabilitation for major surgical procedures in older patients to reduce complication rates and costs: A randomized, prospective, monocentric, multidisciplinary study (PREHABIL study).

  • Krankheitskategorie Andere , Chirurgie (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Bern
    (BASEC)
  • Studienverantwortliche Dominique Engel dominique.engel@insel.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 05.05.2025 ICTRP: Import vom 16.11.2024
  • Letzte Aktualisierung 05.05.2025 19:01

Zusammenfassung der Studie

Participants will be randomly assigned to one of two groups. In the first group, the control group, preparation is done according to the usual method in the treating clinic (orthopedics, urology, abdominal surgery, etc.). In the second group, the intervention group, a multistage preparation is conducted. This consists of an individually tailored package of physical exercise under physiotherapeutic guidance, preventive treatment of any potential anemia, correction of malnutrition, and support for smoking cessation. With your consent, the treating surgeon will refer you to us. First, a series of examinations (strength and endurance tests, blood analyses) will be conducted, as well as some questionnaires to be filled out. If you are assigned to the intervention group, we will then begin the aforementioned preparations over a period of two to four weeks. If you belong to the control group, this step will be omitted. The day before the surgery, this examination will be repeated to assess the effect of the interventions. Four weeks after the surgery, you will receive questionnaires from us again. Your time commitment may vary significantly depending on group assignment. For the control group, we estimate a commitment of about 8 hours, spread over 3 to 4 hospital visits. For the intervention group, at least two additional hospital visits for training guidance of one hour each, along with the time commitment for home training (5x30min/week) and possibly consultations in the clinic for nutritional counseling (30min each) will be added. We try to minimize your commitment by combining visits to the various clinics (operating clinic, anesthesia, physiotherapy, nutritional counseling) whenever possible.

(BASEC)

Untersuchte Intervention

Multimodal pre-habilitation: physical activity, anemia (low blood count) correction, diet optimization and smoking cessation.

(BASEC)

Untersuchte Krankheit(en)

The study examines whether it is possible to positively influence recovery after surgery with multimodal (multi-stage) preparation of the patient. We hope to prevent possible complications and ultimately reduce the follow-up costs of the intervention.

(BASEC)

Kriterien zur Teilnahme
You are about to have a major surgical procedure, are over 65 years old and have a combination of pre-existing conditions (e.g. diabetes, obesity or smoker's lungs) that may increase the risk for the surgical procedure. (BASEC)

Ausschlusskriterien
Illnesses or infirmities that make it impossible to participate in physical exercise (cognition, paralysis, severe pain). Regular blood washing in kidney failure. Palliative or emergency surgeries. (BASEC)

Studienstandort

Bern

(BASEC)

Switzerland (ICTRP)

Sponsor

not applicable

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Dominique Engel

0041316320134

dominique.engel@insel.ch

Department of Anaesthesiology and Pain Therapy Inselspital, Bern University Hospital Freiburgstrasse 3010 Bern

(BASEC)

Allgemeine Auskünfte

Department of Anaesthesiology and Pain Therapy, University Hospital Bern,

0041316322111;00316322111

dominique.engel@insel.ch

(ICTRP)

Wissenschaftliche Auskünfte

Department of Anaesthesiology and Pain Therapy, University Hospital Bern,

0041316322111;00316322111

dominique.engel@insel.ch

(ICTRP)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

13.07.2021

(BASEC)


ICTRP Studien-ID
NCT04461301 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Multimodal prehabilitation for major surgery in elderly patients to lower complications: A randomised, prospective, multi-centre, multidisciplinary trial (PREHABIL Trial). (BASEC)

Wissenschaftlicher Titel
Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial). (ICTRP)

Öffentlicher Titel
Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (ICTRP)

Untersuchte Krankheit(en)
Frail Elderly Syndrome;Major Surgery (ICTRP)

Untersuchte Intervention
Procedure: Multimodal Prehabilitation (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 65 Years
Inclusion Criteria:

- Written informed consent

- comorbid (=ASA 3)

- pre-existing fitness deficit: AT<11ml/kg/min respectively VO2peak<14ml/kg/min if AT
unavailable or VE/VCO2 slope > 33

- scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular
surgery

- screening at least 2 weeks prior to surgery

Exclusion Criteria:

- Paralysis or patients with mobility problems (who are unable to exercise),

- Premorbid conditions or orthopaedic impairments that contraindicate exercise,

- Cognitive disabilities,

- Chronic renal failure (need for dialysis)

- Emergency procedures. (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Comprehensive Complication Index (CCI) (ICTRP)

Cardiovascular & Pulmonary;Nutrition & Bioimpendance;Anaemia;Smoking;Questionnaires for recovery, anxiety and cardiac risk (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
University of Bern;Department of clinical research, Bern (ICTRP)

Weitere Kontakte
Dominique A Engel, Dr;Dominique A Engel, Dr;Dominique A Engel, Dr, dominique.engel@insel.ch, 0041316322111;00316322111, Department of Anaesthesiology and Pain Therapy, University Hospital Bern, (ICTRP)

Sekundäre IDs
PREHAB2020 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04461301 (ICTRP)

Ergebnisse der Studie

Zusammenfassung der Ergebnisse

nicht verfügbar

Link zu den Ergebnissen im Primärregister

nicht verfügbar