NCT02610790

Brief Summary

The aim of this study is to quantify pre- and postoperative physical activity of patients operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be recorded from 15 days before surgery to the end of hospitalization after surgery in a prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the investigators will propose physical activity thresholds (adapted to the age, gender and patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After Surgery). Thus, this analysis will allow the investigators to provide patients with physical rehabilitation programs "a la carte" during a hospitalization for colorectal surgery. Connected bracelets will directly involve patients in their care and rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

November 8, 2015

Last Update Submit

October 22, 2018

Conditions

Physical Activity

Keywords

connected bracelets, footsteps

Outcome Measures

Primary Outcomes (1)

  • Pre- and postoperative physical activity

    Number of footsteps

    30 days

Secondary Outcomes (4)

  • Quality of life

    30 days

  • Quality of sleep

    30 days

  • Pain

    30 days

  • Fatigue

    30 days

Study Arms (1)

Connected bracelet

Patients with a colorectal surgery planned will be included. Fifteen days before surgery, patients will have a connected bracelet permitting to quantify the number of steps and distance achieved each day before surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergo colorectal surgery

You may qualify if:

  • \. Patients with a colorectal surgery

You may not qualify if:

  • Limitation of linguistic or cognitive abilities, interfering with the understanding of the study protocol
  • Lack of consent of the study form
  • Emergency Surgery
  • stoma closure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nicolas DEMARTINES

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Department

Study Record Dates

First Submitted

November 8, 2015

First Posted

November 20, 2015

Study Start

June 1, 2016

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

CH(1)