NCT02834338

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

July 26, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

June 15, 2016

Last Update Submit

October 19, 2017

Conditions

Pancreatic ResectionLiver ResectionGastric ResectionColorectal Resection

Keywords

activity trackingpostoperative recoveryERASfast-track surgery

Outcome Measures

Primary Outcomes (1)

  • Median Step count

    First to fifth postoperative day

Secondary Outcomes (12)

  • Percentage of patients, who master the predefined mobilization (step-count) targets

    First to fifth postoperative day

  • Distance (km)

    First to fifth postoperative day

  • Activity time (min.)

    First to fifth postoperative day

  • inactivity

    First to fifth postoperative day

  • calorie consumption (kcal)

    First to fifth postoperative day

  • +7 more secondary outcomes

Study Arms (4)

Laparoscopic surgery, control

NO INTERVENTION

The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out.

Laparoscopic surgery, intervention

ACTIVE COMPARATOR

activity tracking for autofeedback

Device: activity tracking for autofeedback

Open surgery, control

NO INTERVENTION

The control group is wearing an activity tracker wristband with covered display, so that the step count can't be read out.

Open surgery, intervention

ACTIVE COMPARATOR

activity tracking for autofeedback

Device: activity tracking for autofeedback

Interventions

activity tracking for autofeedbackDEVICE

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.

Laparoscopic surgery, interventionOpen surgery, intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic and open surgery of the colon and rectum (colectomy, hemicolectomy, segment resection, rectum extirpation, deep anterior rectum resection, sigmoid resection, proctocolectomy), of the stomach (total, subtotal and atypical gastric resections), of the pancreas (any kind of pancreatic resections), and of the liver (hemihepatectomy, atypical resection, anatomical segment resection)
  • ASA score \< IV
  • completed informed consent.

You may not qualify if:

  • emergency surgery
  • mental inability to complete postoperative assessment protocols
  • preoperatively immobile patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden

Dresden, 01309, Germany

Location

Related Publications (2)

  • Wolk S, Linke S, Bogner A, Sturm D, Meissner T, Mussle B, Rahbari NN, Distler M, Weitz J, Welsch T. Use of Activity Tracking in Major Visceral Surgery-the Enhanced Perioperative Mobilization Trial: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Jun;23(6):1218-1226. doi: 10.1007/s11605-018-3998-0. Epub 2018 Oct 8.

    PMID: 30298422DERIVED

  • Wolk S, Meissner T, Linke S, Mussle B, Wierick A, Bogner A, Sturm D, Rahbari NN, Distler M, Weitz J, Welsch T. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1.

    PMID: 28222805DERIVED

Study Officials

  • Thilo Welsch, MD, MBA

    Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 15, 2016

Study Start

July 26, 2016

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)