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
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Care Colorectal Surgery||Other: Very early mobilization||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Blood pressure during the SOMS intervention. [ Time Frame: one day ]Blood pressure are registered during the intervention.
- Pulse during the SOMS intervention. [ Time Frame: one day ]Number of heartbeats are registered during the intervention with a device on the patients finger.
- Oxygen saturation during the SOMS intervention. [ Time Frame: one day ]Oxygen saturation are registered during the intervention with a device on the patients finger.
- Pain [ Time Frame: one day ]Pain experienced by the patient during the SOMS intervention, rated using a Visual analogue scale 0-100.
- Presence of vertigo [ Time Frame: one day ]Vertigo experienced by the patient during the SOMS intervention, presence rated as yes/no.
- 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.
- 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.
- 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.
- 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.
- 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
- Self-perceived health and physical function level one year after surgery [ Time Frame: one year ]Using the WHODAS questionnaire, self-reported
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357497
|Contact: Jan Stepniewski, M.D.||+46 19 firstname.lastname@example.org|
|Contact: Rose-Marie Wilnerzon-Thörn, M.Sc.||+46 19 6027646|
|Örebro, Sweden, 70185|
|Principal Investigator:||Rebecca Ahlstrand, M.D. PhD||Region Örebro Län|
|Principal Investigator:||Anette Forsberg, PhD||Region Örebro Län|