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Very Early Mobilization of Colorectal Surgery Patients

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ClinicalTrials.gov Identifier: NCT03357497
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Region Örebro County

Brief Summary:
Early mobilization is an important part of Enhanced Recovery Programs (ERP)in colorectal surgery. The aim of this randomized controlled trial is to investigate the impact of very early mobilization, starting within 1 hour after surgery, on further mobilization within an existing Enhanced Recovery Program.

Condition or disease Intervention/treatment Phase
Postoperative Care Colorectal Surgery Other: Very early mobilization Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Very Early Mobilization of Colorectal Surgery Patients - A Randomized Controlled Trial
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: Very early mobilization
This group will be mobilized in the post-operative unit by a designated physiotherapist. The intervention will be conducted accordingly with the SOMS protocol.
Other: Very early mobilization
The patient will be mobilized by a physiotherapist in our postoperative care unit. The intervention uses the SOMS protocol.

No Intervention: Standard post-operative care
This group will receive standard post-operative care. Mobilization will only take place if the patient request it or to facilitate god post-operative care.



Primary Outcome Measures :
  1. Physical activity level measured with accelerometry [ Time Frame: 72 hours ]
    Comparison between intervention and standard-care group by measurements of physical activity level with an accelerometer that the patient wears during the day. The accelerometer is worn at hip level.


Secondary Outcome Measures :
  1. Time out of bed measured with a protocol [ Time Frame: 7 days ]
    Comparison between intervention and standard-care group, analysis of time out of bed and thus compliance to ERP goals using written documentation in the surgical ward.

  2. Minutes in the postoperative ward [ Time Frame: one year ]
    To ascertain if this intervention is cost effective by comparing time in the post-operative unit between intervention and standard care group.

  3. Days in the hospital ward [ Time Frame: one year ]
    To ascertain if this intervention is cost effective by comparing total hospital stay time between intervention and standard care group.

  4. Number of adverse events during the SOMS intervention. [ Time Frame: one day ]
    Frequency of adverse events during the intervention using the SOMS-protocol. Adverse events here are abnormal blood pressure, pulse, oxygen saturation %, respiratory rate, pain, presence of vertigo, presence of nausea and vomiting.

  5. Blood pressure during the SOMS intervention. [ Time Frame: one day ]
    Blood pressure are registered during the intervention.

  6. Pulse during the SOMS intervention. [ Time Frame: one day ]
    Number of heartbeats are registered during the intervention with a device on the patients finger.

  7. Oxygen saturation during the SOMS intervention. [ Time Frame: one day ]
    Oxygen saturation are registered during the intervention with a device on the patients finger.

  8. Pain [ Time Frame: one day ]
    Pain experienced by the patient during the SOMS intervention, rated using a Visual analogue scale 0-100.

  9. Presence of vertigo [ Time Frame: one day ]
    Vertigo experienced by the patient during the SOMS intervention, presence rated as yes/no.

  10. Presence of nausea [ Time Frame: one day ]
    Nausea experienced by the patient during the SOMS intervention, presence rated as yes/no. If patient vomits due to nausea is also rated yes/no.

  11. 6 minute Walking test [ Time Frame: 6 weeks ]
    Physical capacity measured with the 6 minute Walking test. The number of meters a patient walks during 6 minutes.

  12. Timed up and Go (TUG) test [ Time Frame: 6 weeks ]
    Test of functional mobility. The patient sits on a chair, rises and walks 3 meters, turns och walks back and sits down on the chair. Time in seconds to perform the test.

  13. Patient perception of the SOMS intervention [ Time Frame: 6 weeks ]
    Semi structured telephone interview with patients in the intervention group about their perception of the intervention.

  14. Severity of post-operative complications [ Time Frame: one year ]
    Monitoring number and frequency of patient complications with review of patient records using Clavien-Dindo complication classification

  15. Self-perceived health and physical function level one year after surgery [ Time Frame: one year ]
    Using the WHODAS questionnaire, self-reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients over the age of 18 scheduled for colorectal surgery

Exclusion Criteria:

  • Unable to understand study information (language,cognitive impairment, etc.)
  • Unable to walk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357497


Contacts
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Contact: Jan Stepniewski, M.D. +46 19 6025199 jan.stepniewski@regionorebrolan.se
Contact: Rose-Marie Wilnerzon-Thörn, M.Sc. +46 19 6027646

Locations
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Sweden
Universitetssjukhuset Örebro Recruiting
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Investigators
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Principal Investigator: Rebecca Ahlstrand, M.D. PhD Region Örebro Län
Principal Investigator: Anette Forsberg, PhD Region Örebro Län

Publications:

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Responsible Party: Region Örebro County
ClinicalTrials.gov Identifier: NCT03357497     History of Changes
Other Study ID Numbers: 230961
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Örebro County:
colorectal surgery, early mobilization, postoperative care