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 个研究点目标入组 348 人开始时间: 2019年3月6日最近更新: 2024年8月19日

试验速览

暂无简介。

•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)

发起方

niversitätsklinikum Ulm