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Early Mobilization After Colorectal Surgery

Primary Purpose

Colonic Diseases, Rectal Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Facilitated early mobilization
Usual care
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Diseases focused on measuring colorectal surgery, postoperative recovery, early mobilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Facilitated early mobilization

Usual care

Arm Description

Early mobilization facilitated by a dedicated health professional

Instructions about early mobilization covered in a preoperative education session

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time out of bed (sitting and standing)
Measured by an activity monitor (Actigraph) worn over the participants' hip
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).
Time to recovery of gastrointestinal motility
Time to achieve criteria for recovery of gastrointestinal transit (tolerance of solid diet and bowel movement)
Postoperative fatigue (Multidimensional Fatigue Inventory)
Self-reported physical activity status (Duke Activity Status Index)
Mobility (Life-Space Mobility Assessment)
Condition-specific health-related quality of life (Abdominal Surgery Impact Scale)
Generic heath-related quality of life (RAND-36)
Postoperative complications
Classified according to Clavien-Dindo Index and converted into a continuous scale using the Comprehensive Complication Index
Pulmonary function (spirometry)
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and cough expiratory flow (CEF) will be recorded

Full Information

First Posted
March 28, 2014
Last Updated
March 2, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Mitacs
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1. Study Identification

Unique Protocol Identification Number
NCT02131844
Brief Title
Early Mobilization After Colorectal Surgery
Official Title
Facilitation of Early Mobilization After Colorectal Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Mitacs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases, Rectal Diseases
Keywords
colorectal surgery, postoperative recovery, early mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facilitated early mobilization
Arm Type
Experimental
Arm Description
Early mobilization facilitated by a dedicated health professional
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Instructions about early mobilization covered in a preoperative education session
Intervention Type
Other
Intervention Name(s)
Facilitated early mobilization
Other Intervention Name(s)
Early ambulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Preoperative education
Intervention Description
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)
Primary Outcome Measure Information:
Title
Functional walking capacity (six-minute walk test)
Description
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)
Time Frame
before surgery; 4 weeks after surgery
Secondary Outcome Measure Information:
Title
Time out of bed (sitting and standing)
Description
Measured by an activity monitor (Actigraph) worn over the participants' hip
Time Frame
postoperative day (POD) 0, 1, 2 and 3
Title
Time to readiness for discharge
Description
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 Frame
duration of hospital stay (expected average of 3 days after surgery)
Title
Time to recovery of gastrointestinal motility
Description
Time to achieve criteria for recovery of gastrointestinal transit (tolerance of solid diet and bowel movement)
Time Frame
Expected average of 2 days after surgery
Title
Postoperative fatigue (Multidimensional Fatigue Inventory)
Time Frame
before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery.
Title
Self-reported physical activity status (Duke Activity Status Index)
Time Frame
before surgery; 2 weeks after surgery; 4 weeks after surgery
Title
Mobility (Life-Space Mobility Assessment)
Time Frame
before surgery; 4 weeks after surgery
Title
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
Title
Generic heath-related quality of life (RAND-36)
Time Frame
before surgery; 4 weeks after surgery
Title
Postoperative complications
Description
Classified according to Clavien-Dindo Index and converted into a continuous scale using the Comprehensive Complication Index
Time Frame
up to 4 weeks after surgery
Title
Pulmonary function (spirometry)
Description
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and cough expiratory flow (CEF) will be recorded
Time Frame
before surgery; POD 1, 2 and 3; 4 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liane S Feldman, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio F Fiore Junior, PhD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Mayo, PhD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franco Carli, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32324693
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.
Results Reference
derived
PubMed Identifier
27997472
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.
Results Reference
derived

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Early Mobilization After Colorectal Surgery

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