Prehabilitation before oncological surgery
Conditions
Interventions
Group 1: The intervention group will receive a supervised progressive exercise programme conducted and supervised by a professional sport therapist, consisting of three 50-min sessions per week. Each
Sponsors
Uniklinik Köln
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Candidate to elective major gastrointestinal cancer surgery (pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, pancreatectomy, rectum resection); 2) High risk for surgical complications defined by presence of comorbid disease such as deconditioning, heart disease, diabetes, renal impairment or morbid obesity; 3) Duke Activity Status Index score (DASI) <402; 5) Schedule allowing for at least 4 weeks for intervention with multimodal prehabilitation prior to surgery / willingness to exercise
Exclusion criteria
Exclusion criteria: 1) Non-elective surgery; 2) Unstable cardiac or respiratory disease; 3) Locomotor limitations precluding exercise training; 4) Cognitive deterioration impeding adherence to the programme; 5) Enrolment in other research studies affecting study endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is postoperative complications (Clavien-Dindo Classification grade III-V). Observation period will be 90 days. Clavien-Dindo Classification is a well-known, metric and validated outcome parameter that is sensitive to surgical risk and prognostic association to long-term (five-year) survival in cancer patients. We will analyse this outcome in the context of clinically relevant time window (30days after surgery or time of patient’s discharge), where, based on our preliminary data, most of the CDIII-V complications occur. Preliminary prehabilitation studies have shown that it is feasible to exercise patients preoperatively and improve functional capacity. Yet to date, there are no adequately powered multicentre, randomised, controlled trials investigating on the efficacy of prehabilitation on postoperative complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include postoperative Comprehensive Complication Index (CCI), medical complications (i.e. cardiac, pulmonary, sepsis => all complications will be predefined in protocol), length of ICU stay (LOICUS), Hospital Length of Stay (HLOS), Days at home after surgery (DAH-30), cost-effectiveness / -utility analysis (RAND, iPCQ/iMCQ), functional capacity (CPET, DASI) and quality of life (HRQoL, EORTC QLQ-C30). | — |
Countries
Germany
Contacts
Public ContactRobert Schier
Uniklinik Köln
Outcome results
None listed