Clinical trial NCT03357497: Very Early Mobilization of Colorectal Surgery Patients
Official title: Very Early Mobilization of Colorectal Surgery Patients - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Care
Colorectal Surgery
Keywords: colorectal surgery, early mobilization, postoperative care
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Physical activity level measured with accelerometry
timeFrame: 72 hours
Secondary outcomes:
measure: Time out of bed measured with a protocol
timeFrame: 7 days
measure: Minutes in the postoperative ward
timeFrame: one year
measure: Days in the hospital ward
timeFrame: one year
measure: Number of adverse events during the SOMS intervention.
timeFrame: one day
measure: Blood pressure during the SOMS intervention.
timeFrame: one day
measure: Pulse during the SOMS intervention.
timeFrame: one day
measure: Oxygen saturation during the SOMS intervention.
timeFrame: one day
measure: Pain
timeFrame: one day
measure: Presence of vertigo
timeFrame: one day
measure: Presence of nausea
timeFrame: one day
measure: 6 minute Walking test
timeFrame: 6 weeks
measure: Timed up and Go (TUG) test
timeFrame: 6 weeks
measure: Patient perception of the SOMS intervention
timeFrame: 6 weeks
measure: Severity of post-operative complications
timeFrame: one year
measure: Self-perceived health and physical function level one year after surgery
timeFrame: one year
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
Study officials:
affiliation: Region Örebro Län
name: Rebecca Ahlstrand, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Region Örebro Län
name: Anette Forsberg, PhD
role: PRINCIPAL_INVESTIGATOR
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