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Clinical Trials/DRKS00016755
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.

Registry
who.int
Start Date
March 6, 2019
End Date
November 22, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversitätsklinikum Ulm

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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