Enhanced Perioperative Mobilization (EPM) Trial

Liver Resection Clinical Trial

— EPMIII  

Official title:

Usage of Activity Tracking in Major Visceral Surgery - the Enhanced Perioperative Mobilization (EPM) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834338
• Other study ID #: TW-003
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: October 19, 2017
• Start date: July 26, 2016
• Est. completion date: July 20, 2017

Study information

• Verified date: October 2017
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients undergoing elective open and laparoscopic surgery of colon, rectum, stomach, pancreas and liver for any indication will be included. Further inclusion criteria are: age between 18-75 years, ASA score < 4, and a signed informed consent. Patients are stratified into two subgroups (laparoscopic and open surgery) and will be randomized 1:1 for an autofeedback of their step-count using an activity tracker wristband or for the control group without autofeedback. Sample size (n = 29 patients in each of the four groups, overall n = 119) is calculated on an assumed difference in step-count of 250 steps daily (intervention versus control group). The primary study endpoint is the step-count during the first five postoperative days; secondary endpoints are the percentage of patients in the two groups, who master the predefined mobilization (step-count) targets, the assessment of additional activity data from the devices, the assessment of the preoperative mobility, length of hospital and intensive care unit stay, number of patients who receive physiotherapy, 30-day mortality, and the overall 30-day morbidity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• emergency surgery

• mental inability to complete postoperative assessment protocols

• preoperatively immobile patients

Related Conditions & MeSH terms

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

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Step count		First to fifth postoperative day
Secondary	Percentage of patients, who master the predefined mobilization (step-count) targets		First to fifth postoperative day
Secondary	Distance (km)	Assessed by the activity tracker wristband	First to fifth postoperative day
Secondary	Activity time (min.)	Assessed by the activity tracker wristband	First to fifth postoperative day
Secondary	inactivity	Assessed by the activity tracker wristband	First to fifth postoperative day
Secondary	calorie consumption (kcal)	Assessed by the activity tracker wristband	First to fifth postoperative day
Secondary	Compliance	Compliance to wear the wrist band	First to fifth postoperative day
Secondary	Assessment of the preoperative mobility	Measured by International Physical Activity Questionnaire (IPAQ)	Preoperative
Secondary	Length of hospital stay		30 days
Secondary	Length of ICU stay		30 days
Secondary	Amount of patients which receive physiotherapy		First to fifth postoperative day
Secondary	Mortality		30 days
Secondary	Overall morbidity	According the Clavien-Dindo classification	30 days