C18 C16 C25 C22.0 C15
Conditions
Interventions
Group 1: The study will include patients aged 18 and older who are scheduled to undergo gastrointestinal tumor resection in the field of visceral surgery and who meet the requirements for participatio
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with planned gastrointestinal tumor resections who have a period of at least two weeks between study inclusion and surgery Additional inclusion criteria for participation in the prehabilitation program and process and outcome evaluation (primary data collection): ? Patients for whom there is a period of at least two weeks between study inclusion and surgery. ? Additional criterion for participation in the prehabilitation program: availability of the consent form for participation in the program and the process and outcome evaluation. ? Additional criterion for participation in the process and outcome evaluation: availability of the consent form for participation in the process and outcome evaluation.
Exclusion criteria
Exclusion criteria: ? Current participation in another intervention study ? Any diseases or functional impairments that, in the opinion of the examining physician, preclude participation in a physical training intervention. This also includes oncology-specific symptoms such as: - inability to undergo surgery - Karnofsky index =40% / ECOG index =3 - uncontrolled bleeding - Hb values < 8 g/dl - Regular hypoglycemia - Severe electrolyte imbalances - Severe neutropenia - Severe heart failure - Uncontrolled hypertension - Severe arrhythmia - Acute pulmonary embolism - Severe neurological deficits - Bone metastases with high risk of fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints/target parameters of the process evaluation: • Recruitment rate: Patients who newly participate in prehabilitation within a period of 12 months / patients who are eligible for prehabilitation within a period of 12 months according to the inclusion criteria. • Screening failure rate: Patients who do not participate in prehabilitation within a period of 12 months / patients who are eligible for prehabilitation according to the inclusion criteria within a period of 12 months. • Dropout rate: Patients who drop out within a period of 12 months after inclusion in the program / patients who participate in prehabilitation within a period of 12 months (if the questionnaires are not answered in the follow-up at 3, 6, 9, and 12 months post-op) • Reasons for non-participation • Reasons for discontinuing the program (questionnaire via digital questionnaires if the questionnaires are not completed at the 3-, 6-, 9-, and 12-month post-op follow-ups) Primary endpoints/target parameters for the evaluation of results: • Evaluation of physical activity using a questionnaire (IPAQ) • Subjective quality of life using a questionnaire (European Organization for Research and Treatment of Cancer EORTC QLQ-C30) -> Survey at baseline and after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints/target parameters for outcome evaluation: • Body composition: (fat [%], muscle mass [kg]) • Handgrip strength • Fatigue symptoms using questionnaire (Fatigue Assessment Scale [FAS]) • Frailty using the Hannover Frail Scale (questionnaire-based) -> Survey at baseline and after 12 months • Further care of patients postoperatively (questionnaire-based) • Occurrence of postoperative complications during hospitalization, defined according to the Clavien-Dindo classification. • Length of hospital stay. • Readmission due to complications associated with the procedure within 30 days of discharge -> Baseline survey | — |
Countries
Germany
Contacts
Public ContactLinda Feldbrügge
Medizinische Hochschule Hannover
Outcome results
None listed