Clinical trial NCT02131844: Early Mobilization After Colorectal Surgery
Official title: Facilitation of Early Mobilization After Colorectal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diseases
Rectal Diseases
Keywords: colorectal surgery
postoperative recovery
early mobilization
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Mitacs
First posted: 2014-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Functional walking capacity (six-minute walk test)
timeFrame: before surgery; 4 weeks after surgery
Secondary outcomes:
measure: Time out of bed (sitting and standing)
timeFrame: postoperative day (POD) 0, 1, 2 and 3
measure: Time to readiness for discharge
timeFrame: duration of hospital stay (expected average of 3 days after surgery)
measure: Time to recovery of gastrointestinal motility
timeFrame: Expected average of 2 days after surgery
measure: Postoperative fatigue (Multidimensional Fatigue Inventory)
timeFrame: before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery.
measure: Self-reported physical activity status (Duke Activity Status Index)
timeFrame: before surgery; 2 weeks after surgery; 4 weeks after surgery
measure: Mobility (Life-Space Mobility Assessment)
timeFrame: before surgery; 4 weeks after surgery
measure: Condition-specific health-related quality of life (Abdominal Surgery Impact Scale)
timeFrame: before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery
measure: Generic heath-related quality of life (RAND-36)
timeFrame: before surgery; 4 weeks after surgery
measure: Postoperative complications
timeFrame: up to 4 weeks after surgery
measure: Pulmonary function (spirometry)
timeFrame: before surgery; POD 1, 2 and 3; 4 weeks after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Liane S Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Julio F Fiore Junior, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Nancy Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Franco Carli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balvardi S, Pecorelli N, Castelino T, Niculiseanu P, Alhashemi M, Liberman AS, Charlebois P, Stein B, Carli F, Mayo NE, Feldman LS, Fiore JF Jr. Impact of Facilitation of Early Mobilization on Postoperative Pulmonary Outcomes After Colorectal Surgery: A Randomized Controlled Trial. Ann Surg. 2021 May 1;273(5):868-875. doi: 10.1097/SLA.0000000000003919.
citation: Fiore JF Jr, Castelino T, Pecorelli N, Niculiseanu P, Balvardi S, Hershorn O, Liberman S, Charlebois P, Stein B, Carli F, Mayo NE, Feldman LS. Ensuring Early Mobilization Within an Enhanced Recovery Program for Colorectal Surgery: A Randomized Controlled Trial. Ann Surg. 2017 Aug;266(2):223-231. doi: 10.1097/SLA.0000000000002114.