C22.0 C22.1 C24.0 C25 C23 C24
Conditions
Interventions
Group 1: Six-week perioperative exercise program (starting 14 days before surgery and lasting 28 days after surgery)
Group 2: Control group, standard treatment according to the ERAS (Enhanced Recovery
Sponsors
Universitätsklinikum Ulm, Klinik für Allgemein- und Viszeralchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients undergoing elective curative-intent surgery for suspected or biopsy-proven malignancies of the liver, biliary tract or periampullary/pancreatic tumors - Age = 18 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Ability to safely complete a 6-minute walking test (6MWT) with a clinically acceptable heart rate and blood pressure response - Clearance for physical activity based on PAR-Q screening (negative PAR-Q or medical clearance in case of a positive result) - Written informed consent
Exclusion criteria
Exclusion criteria: • Planned two- or multi-staged surgeries within 6 weeks • Patients during pregnancy and breastfeeding • Comorbidities precluding an exercise program as determined by the investigator • History of other treated or non-treated malignancies in the past 2 years • Impaired mental state or language barrier • Suspected lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the intervention, as defined by predefined criteria addressing recruitment rate ( =70%) and randomization performance (=90%), increase of physical activity (=25%) in the intervention group compared with the control group, and safety and adherence (=70%) of the exercise program. | — |
Secondary
| Measure | Time frame |
|---|---|
| Circulating myeloid-derived suppressor cells (Baseline, preoperatively on Day 14 and Day 1, at discharge, on postoperative day 28, day 90, and 6 months post-op), Biochemical blood tests (Baseline, preoperatively on Day 14 and Day 1, at discharge, on postoperative day 28, day 90, and 6 months post-op), Body composition (Baseline, preoperatively on Day 14 and Day 1, at discharge, on postoperative day 28, day 90, and 6 months post-op), Physical activity (IPAQ-SF) (Baseline, preoperatively on Day 14 and Day 1, at discharge, on postoperative day 28, day 90, and 6 months post-op), Muscle strength (hand-grip strength)(Baseline, preoperatively on Day 14 and Day 1, at discharge, on postoperative day 28, day 90, and 6 months post-op), Endurance capacity (6-minute walk test)(Baseline, preoperatively on Day 14 and Day 1, at discharge, on postoperative day 28, day 90, and 6 months post-op), Evaluation of the exercise program, Type and extent of surgery, Surgical approach, Operating time, Total blood loss, Need for perioperative blood transfusions, Postoperative length of hospital stay, Postoperative stay in intermediate/intensive care unit, Time-to-functional recovery, Need for invasive interventions (until POD 90), Pathological characteristics, Frequency of perioperative medical events (until POD 90), Frequency of perioperative surgical events (until POD 90), 90-day morbidity (Clavien–Dindo classification), Readmission rate (until POD 90), Planned oncological therapy and treatment response (6 months), Quality of life (QLQ-C30, EQ-5D-5L)(Baseline, after 90 days, after 6 months), Recurrence-free survival (6 months), Progression-free-survival (6 months), Overall survival (6 months) | — |
Countries
Germany
Contacts
Public ContactEmrullah Birgin
Universitätsklinikum Ulm, Klinik für Allgemein- und Viszeralchirurgie
Outcome results
None listed