Patients undergoing major abdominal surgery
Conditions
Interventions
Group 1: Patients are fitted with a wearable fitness tracker on their wrist for the duration of their postoperative stay until discharge or a maximum of 30 days. Patients receive real-time visual feed
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Preoperative inclusion criteria: 1. Patients scheduled for elective major abdominal surgery defined as procedures expected to last more than 2 hours, or with an anticipated blood loss greater than 500 ml 2. Ability to understand the character and individual consequences of the clinical trial 3. Open or laparoscopic or robotic surgery or any variant (laparoscopic-assisted, hybrid procedures etc.) 4. Written informed consent 5. Age =18 years Intra-/postoperative inclusion criteria: 1. Expected postoperative stay on the intensive care or intermediate care ward is less than 4 days. 2. No planned reoperation within 30 days 3. Confirmed major abdominal surgery (=defined as procedures expected to last more than 2 hours, or with an anticipated blood loss greater than 500 ml.
Exclusion criteria
Exclusion criteria: 1. American Society of Anesthesiologists (ASA) grade >3 2. Preoperative immobility or inability to walk unaided 3. Participation in another interventional trial with interference of intervention and outcome of this study 4. Expected postoperative stay on the intensive care or intermediate care ward >= 4 days 5. Planned reoperation within 30 days after index operation 6. Planned abdominal-thoracic operations (two-field surgeries)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative complications measured via the comprehensive complication index (CCI) within 30 days after the index operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of steps until POD 8 or until discharge. 2. QoR-15 at baseline and on POD 4 (or at discharge) 3. Activity data until discharge or a maximum of 30 days. 4. Health-related quality of life measured via the EORTC QLQ-C30 at baseline, on POD 8 (or discharge, whatever comes first) and on postoperative day 30 5. 6-minute walking test at POD 6 (or discharge, whatever comes first) 6. Time until return of bowel function measured via the GI-2 score 7. Postoperative pulmonary complications according to the Melbourne group score during hospital stay 8. Deep vein thrombosis until POD 30 9. Pulmonary embolism until POD 30 10. Time from day of index surgery to achieve uninterrupted ambulation greater than 10 min. 11. 30-day mortality 12. Length of hospital stay 13. Discharge destination from the acute hospital ward 14. Pain via the numeric rating scale on POD 2,4,6 at rest and during movement 15. Postoperative unintended falls/collapses until day of discharge | — |
Countries
Germany
Contacts
Public ContactAndré Mihaljevic
Klinik für Allgemein- und ViszeralchirurgieUniversitätsklinikum Ulm
Outcome results
None listed