Multicenter randomized controlled trial exploring postoperative complications and mobilization following major abdominal surgery with vs. without fitness tracker-based feedback (EXPELLIARMUS) - a CHIR-Net Student-Initiated German Medical Audit trial (CHIR-Net SIGMA trial)
- Conditions
- Patients undergoing major abdominal surgery
- Registration Number
- DRKS00016755
- Lead Sponsor
- niversitätsklinikum Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 348
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.
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative complications measured via the comprehensive complication index (CCI) within 30 days after the index operation.
- Secondary Outcome Measures
Name Time Method 1. Number of steps until POD 8 or until discharge. <br>2. QoR-15 at baseline and on POD 4 (or at discharge) <br>3. Activity data until discharge or a maximum of 30 days.<br>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 <br>5. 6-minute walking test at POD 6 (or discharge, whatever comes first)<br>6. Time until return of bowel function measured via the GI-2 score <br>7. Postoperative pulmonary complications according to the Melbourne group score during hospital stay<br>8. Deep vein thrombosis until POD 30<br>9. Pulmonary embolism until POD 30<br>10. Time from day of index surgery to achieve uninterrupted ambulation greater than 10 min. <br>11. 30-day mortality<br>12. Length of hospital stay<br>13. Discharge destination from the acute hospital ward <br>14. Pain via the numeric rating scale on POD 2,4,6 at rest and during movement<br>15. Postoperative unintended falls/collapses until day of discharge<br>