Very Early Mobilization of Colorectal Surgery Patients

Not Applicable

Completed

• Conditions: Colorectal Surgery; Postoperative Care

• Registration Number: NCT03357497
• Lead Sponsor: 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.

Detailed Description

Post-operative bed rest and immobility has a negative effect on morbidity and mortality after colorectal surgery.To prevent immobilization early mobilization is a well established part of Enhanced Recovery Programs. This facility uses protocols developed by the ERAS (Enhanced Recovery After Surgery)-society. However not all patients can reach the level physical activity needed to be in compliance with the ERP. This being more frequent in the elderly frail patient. This may contribute to longer hospital stay and increase the risk of complications. The aim of this trial is to investigate if a very early mobilization intervention will lead to a higher lever of physical activity after surgery compared with standard-care.

The aim is to include 150 patients scheduled to undergo colorectal surgery. Patients will receive written and verbal information about the trial before written consent is obtained. The patients will undergo an extended pre-operative assessment during which a baseline for patients physical activity level will be established before surgery. For this purpose the patients will be evaluated by a physiotherapist with the following tools; 6-minutes walk test, Timed up and go-test (TUG), mini modified Functional Independence Measure (mFIM), WHO disability assessment score (WHODAS) and activity measurement with accelerometry for up to 7 days. (Actigraph GT3X device)

The randomization will take place on the day of the surgery and the patients will be assigned to either intervention (very early mobilization) or control group (standard post-operative care). A stratified randomization will be performed to ensure an even spread within three patient categories: Laparoscopic surgery, Open surgery and Rectum amputation. The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.

After surgery the patients will be transferred to the post-operative care unit where the patients included in the intervention group will be mobilized with the help of a physiotherapist and post-operative unit staff. The intervention will begin as early as 30 minutes after arrival in the post-operative unit. The intervention will follow the Surgical ICU Optimal Mobilization Score (SOMS) which includes four steps of mobilization from movement in bed up to walking. Progress from each step to the next will be conditioned with patient fulfilling criteria for a safe mobilization including stable physiological parameters and adequate pain situation. The patients in the standard care group will not receive the intervention.

All patients will receive information about early mobilization. The patients will not receive information on the timing of the mobilization intervention in an effort to remain blinded to the intervention. The patient in the standard care group will be mobilized accordingly to the ERP protocol, which also includes early mobilization in the surgical ward. Upon transfer from the post-operative unit to the surgical ward all study patients will be again fitted with the activity monitor to measure their physical activity during the post-operative phase.

During hospital stay all study patients will be subject to routine mobilization within the existing ERP protocol. To determine the physical activity level the patient will be wearing the activity monitoring device until discharge from the surgical ward. The study patients will also be evaluated by blinded physiotherapists with mFIM and 6 minutes walk-test. In addition information will be gathered regarding routine documentation on patient mobilization progress to measure adherence to ERP goals.

After four to six weeks the patients are scheduled for a standard post-operative follow-up visit. The study patients will then also meet a blinded physiotherapist that previously was not participating in the intervention who will repeat the following tests: 6 minutes walk-test, WHODAS, TUG. All study patients will also be instructed to wear the activity monitor for additional seven days to again measure their physical activity level. All patients who have undergone the intervention will be scheduled for a semi-structured telephone interview about their perception of the SOMS intervention.

Follow-up questionnaire with WHODAS self-reported questions will be gathered through a telephone interview with the patients three, six and twelve months after surgery.

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-30
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical activity level measured with accelerometry	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

Name	Time	Method
Pulse during the SOMS intervention.	one day	Number of heartbeats are registered during the intervention with a device on the patients finger.
Presence of vertigo	one day	Vertigo experienced by the patient during the SOMS intervention, presence rated as yes/no.
Severity of post-operative complications	one year	Monitoring number and frequency of patient complications with review of patient records using Clavien-Dindo complication classification
Time out of bed measured with a protocol	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	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	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.	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.	one day	Blood pressure are registered during the intervention.
Oxygen saturation during the SOMS intervention.	one day	Oxygen saturation are registered during the intervention with a device on the patients finger.
Pain	one day	Pain experienced by the patient during the SOMS intervention, rated using a Visual analogue scale 0-100.
Presence of nausea	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	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	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	6 weeks	Semi structured telephone interview with patients in the intervention group about their perception of the intervention.
Self-perceived health and physical function level one year after surgery	one year	Using the WHODAS questionnaire, self-reported

Trial Locations

Locations (1)

Universitetssjukhuset Örebro; 🇸🇪 Örebro, Sweden