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Enhanced Perioperative Mobilization (EPM) Trial

NCT02834338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-10-20

No results posted yet for this study

Summary

Randomized Controlled Trial to monitor and increase the postoperative mobilization of the patients undergoing major visceral surgery by giving a continuous autofeedback of the step count using activity tracking wristbands.

Conditions

  • Pancreatic Resection
  • Liver Resection
  • Gastric Resection
  • Colorectal Resection

Interventions

DEVICE

activity tracking for autofeedback

The intervention group receives an unblinded wristband. The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted. The target step-count was set at the 85% quartile obtained from a previous pilot study. The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Thilo Welsch, MD, MBA · Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-26
Primary Completion
2017-07-20
Completion
2017-07-20

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02834338 on ClinicalTrials.gov