Patients undergoing colorectal surgery for benign or malignant disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients undergoing elective colon or rectal surgery for benign or malignant disease - Age = 18 years - Able to provide informed consent - No previous participation in or education regarding an ERAS® programme - Physically and cognitively able to participate in postoperative mobilisation (e.g. no pre-existing bedridden status or permanent wheelchair dependence) - No contraindications to wearing an activity tracker - No significant language barrier
Exclusion criteria
Exclusion criteria: - Declined participation in the ERAS® programme - Requirement for postoperative intensive care beyond postoperative day 1 (POD 1) - Abandonment of the planned surgical procedure - Major postoperative complications (Clavien–Dindo Classification grade = IIIb) - Participation in other clinical studies that could influence the study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical activity level, measured as the mean daily step count across postoperative days 1 and 2 (POD 1 and POD 2), as recorded by an activity tracker | — |
Secondary
| Measure | Time frame |
|---|---|
| - Daily step count and physical activity duration (postoperative days 1–5 [POD 1–POD 5]) - Preoperative and postoperative ERAS compliance, assessed for each individual ERAS element as well as the mean compliance preoperatively and postoperatively - Postoperative complications, classified according to the Clavien–Dindo Classification (CDC), until hospital discharge or within 30 days postoperatively - Length of hospital stay - Patient-reported outcome measures (PROMs): EORTC QLQ-C30, EPAT-121, and a study-specific questionnaire | — |
Countries
Germany
Contacts
Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Universitätsklinikum Hamburg-Eppendorf