DRKS00016755
Completed
未知
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) - EXPELLIARMUS
niversitätsklinikum Ulm0 sites348 target enrollmentMarch 6, 2019
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitätsklinikum Ulm
- Enrollment
- 348
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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