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Completed

NCT Number: NCT02131844

Early Mobilization After Colorectal Surgery

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.

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Key information

Conditions

Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facilitated early mobilization

Other

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.

Other names: Early ambulation

Usual Care

Other

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)

Other names: Preoperative education

Primary outcomes

  1. Functional walking capacity (six-minute walk test)

    Time frame: 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 outcomes

  1. Time out of bed (sitting and standing)

    Time frame: postoperative day (POD) 0, 1, 2 and 3

    Measured by an activity monitor (Actigraph) worn over the participants' hip

  2. Time to readiness for discharge

    Time frame: 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).

  3. Time to recovery of gastrointestinal motility

    Time frame: Expected average of 2 days after surgery

    Time to achieve criteria for recovery of gastrointestinal transit (tolerance of solid diet and bowel movement)

  4. Postoperative fatigue (Multidimensional Fatigue Inventory)

    Time frame: before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery.

  5. Self-reported physical activity status (Duke Activity Status Index)

    Time frame: before surgery; 2 weeks after surgery; 4 weeks after surgery

  6. Mobility (Life-Space Mobility Assessment)

    Time frame: before surgery; 4 weeks after surgery

  7. Condition-specific health-related quality of life (Abdominal Surgery Impact Scale)

    Time frame: before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery

  8. Generic heath-related quality of life (RAND-36)

    Time frame: before surgery; 4 weeks after surgery

  9. Postoperative complications

    Time frame: up to 4 weeks after surgery

    Classified according to Clavien-Dindo Index and converted into a continuous scale using the Comprehensive Complication Index

  10. Pulmonary function (spirometry)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Mitacs

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 6, 2014
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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