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Colonic DiseasesNCT02131844

Early Mobilization After Colorectal Surgery

A study testing Facilitated early mobilization in people with Colonic Diseases and Rectal Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colonic Diseases, Rectal Diseases
What is being tested?
Facilitated early mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
Aug 2014to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult people (>18 years)
  • Colonic or rectal diseases (i.e. cancer, inflammatory bowel disease, diverticulitis) planned for surgical resection

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

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

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.

Read the 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).

Being tested
Facilitated early mobilization, Usual care
Keywords
colorectal surgery, postoperative recovery, early mobilization
Medical subject headings
Colonic Diseases, Rectal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Facilitated early mobilizationOther

    Also called Early ambulation

    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 careOther

    Also called Preoperative education

    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)

Study groups in NCT02131844
Study groupRoleWhat they receive
Facilitated early mobilizationExperimentalEarly mobilization facilitated by a dedicated health professional
Receives: Other: Facilitated early mobilization
Usual careActive comparatorInstructions about early mobilization covered in a preoperative education session
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: before surgery; 4 weeks after surgery

Secondary outcomes (10)

  1. Time out of bed (sitting and standing)

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

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

  2. 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).

    Measured: duration of hospital stay (expected average of 3 days after surgery)

  3. Time to recovery of gastrointestinal motility

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

    Measured: Expected average of 2 days after surgery

  4. Postoperative fatigue (Multidimensional Fatigue Inventory)

    Measured: 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)

    Measured: before surgery; 2 weeks after surgery; 4 weeks after surgery

  6. Mobility (Life-Space Mobility Assessment)

    Measured: before surgery; 4 weeks after surgery

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

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

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

    Measured: before surgery; 4 weeks after surgery

  9. Postoperative complications

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

    Measured: up to 4 weeks after surgery

  10. Pulmonary function (spirometry)

    Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and cough expiratory flow (CEF) will be recorded

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02131844
Sponsor's protocol ID
MUHC Study Code 13-329-SDR
Other IDs
Mitacs Elevate Fellowship
Status last verified
Mar 2018
First submitted
28 Mar 2014
Last updated
5 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32324693

  • 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.

    PubMed 27997472

Questions about this trial

What is this clinical trial studying?

A study testing Facilitated early mobilization in people with Colonic Diseases and Rectal Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional walking capacity (six-minute walk test) (time frame: before surgery; 4 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02131844, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.

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