Early Mobilization After Colorectal Surgery

Not Applicable

Completed

• Conditions: Rectal Diseases; Colonic Diseases
• Interventions: Other: Facilitated early mobilization; Other: Usual care

• Registration Number: NCT02131844
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-05-04
• Study First Posted: 2014-05-06
• Study Start: 2014-08
• Primary Completion: 2015-07
• Study Completion: 2016-05
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facilitated early mobilization	Facilitated early mobilization	Early mobilization facilitated by a dedicated health professional
Usual care	Usual care	Instructions about early mobilization covered in a preoperative education session

Primary Outcome Measures

Name	Time	Method
Functional walking capacity (six-minute walk test)	before surgery; 4 weeks after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Time out of bed (sitting and standing)	postoperative day (POD) 0, 1, 2 and 3	Measured by an activity monitor (Actigraph) worn over the participants' hip
Time to readiness for discharge	duration of hospital stay (expected average of 3 days after surgery)	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).
Time to recovery of gastrointestinal motility	Expected average of 2 days after surgery	Time to achieve criteria for recovery of gastrointestinal transit (tolerance of solid diet and bowel movement)
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	up to 4 weeks after surgery	Classified according to Clavien-Dindo Index and converted into a continuous scale using the Comprehensive Complication Index
Pulmonary function (spirometry)	before surgery; POD 1, 2 and 3; 4 weeks after surgery	Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and cough expiratory flow (CEF) will be recorded

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada