Early Mobilization After Colorectal Surgery

Colonic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131844
• Other study ID #: MUHC Study Code 13-329-SDR
• Secondary ID: Mitacs Elevate F
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: March 2, 2018
• Start date: August 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Diseases
• Rectal Diseases

Intervention

Other:
• Facilitated early mobilization
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.
• Usual care
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)

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	Postoperative fatigue (Multidimensional Fatigue Inventory)		before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery.
Secondary	Self-reported physical activity status (Duke Activity Status Index)		before surgery; 2 weeks after surgery; 4 weeks after surgery
Secondary	Mobility (Life-Space Mobility Assessment)		before surgery; 4 weeks after surgery
Secondary	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
Secondary	Generic heath-related quality of life (RAND-36)		before surgery; 4 weeks after surgery
Secondary	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
Secondary	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