Early Mobilization After Colorectal Surgery

Study Overview
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Brief Summary
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Early mobilization (i.e. initiation of out of bed activities from the day of surgery) is considered an important component of postoperative care after colorectal surgery. Having a health professional dedicated to facilitate early mobilization has the potential to enhance postoperative recovery by preventing the negative effects of prolonged bed rest (e.g. increased risk for complications, muscle loss, deconditioning and functional decline); however, the need to implement this resource-intensive approach is not evidence based. This study aims to contribute evidence about the role of facilitated early mobilization as a strategy to enhance recovery after colorectal surgery.

Detailed Description
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The primary research question of this study is: to what extent does postoperative facilitation of early mobilization impact on recovery of functional walking capacity at 4 weeks after surgery in comparison to standard care (preoperative education). The hypothesis is that, by 4 weeks after surgery, facilitated early mobilization will result in a greater proportion of participants returning to preoperative levels of functional walking, as measured by the six-minute walk test (6MWT).

Official Title
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Facilitation of Early Mobilization After Colorectal Surgery: A Randomized Controlled Trial

Conditions
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Colonic Diseases, Rectal Diseases

Intervention / Treatment
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* Other: Facilitated early mobilization
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult people (>18 years) Colonic or rectal diseases (i.e. cancer, inflammatory bowel disease, diverticulitis) planned for surgical resection Exclusion Criteria: Metastatic disease Medical conditions that preclude postoperative mobilization (e.g. neurological or musculoskeletal diseases) Inability to understand English or French Admission to intensive care immediately after the surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facilitated early mobilization<br>Early mobilization facilitated by a dedicated health professional | Other: Facilitated early mobilization<br>* Participants randomized to this group, in addition the preoperative education (usual care), will have early mobilization facilitated by a trained health professional. This health professional will: (1) visit the participant on the day of surgery to reinforce mobilization goals and assist with transfer to a chair and (2) visit the participant three times per day starting from POD 1 to reinforce mobilization goals and walk with the participant (at least the length of the hallway). Targeted walking distances will increase according to the participant's tolerance. This intervention will be undertaken until POD 3 or hospital discharge, whichever comes first.<br>* Other names: Early ambulation;|
| Active Comparator: Usual care<br>Instructions about early mobilization covered in a preoperative education session | Other: Usual care<br>* Participants randomized to this group will receive instructions about postoperative mobilization in a preoperative education session and will receive a booklet describing mobilization goals for each POD (sit in a chair for 2 hours on the day of surgery, stay out of bed for at least 6 hours/day from POD 1 until hospital discharge)<br>* Other names: Preoperative education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional walking capacity (six-minute walk test) | The outcome of interest will be the proportion of participants returning to preoperative levels of functional walking capacity at 4 weeks after surgery (within an estimated measurement error of 20 meters) | before surgery; 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time out of bed (sitting and standing) | Measured by an activity monitor (Actigraph) worn over the participants' hip | postoperative day (POD) 0, 1, 2 and 3 | 
| Time to readiness for discharge | Time to achieve standardized hospital discharge criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self care and no evidence of complications or untreated medical problems). | duration of hospital stay (expected average of 3 days after surgery) | 
| Time to recovery of gastrointestinal motility | Time to achieve criteria for recovery of gastrointestinal transit (tolerance of solid diet and bowel movement) | Expected average of 2 days after surgery | 
| Postoperative fatigue (Multidimensional Fatigue Inventory) |  | before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery. | 
| Self-reported physical activity status (Duke Activity Status Index) |  | before surgery; 2 weeks after surgery; 4 weeks after surgery | 
| Mobility (Life-Space Mobility Assessment) |  | before surgery; 4 weeks after surgery | 
| Condition-specific health-related quality of life (Abdominal Surgery Impact Scale) |  | before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery | 
| Generic heath-related quality of life (RAND-36) |  | before surgery; 4 weeks after surgery | 
| Postoperative complications | Classified according to Clavien-Dindo Index and converted into a continuous scale using the Comprehensive Complication Index | up to 4 weeks after surgery | 
| Pulmonary function (spirometry) | Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and cough expiratory flow (CEF) will be recorded | before surgery; POD 1, 2 and 3; 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal surgery, postoperative recovery, early mobilization