Early Mobilization After Colorectal Surgery

NCT ID: NCT02131844

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-05-31

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).

Conditions

Colonic Diseases; Rectal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Facilitated early mobilization

Early mobilization facilitated by a dedicated health professional

Group Type: EXPERIMENTAL

Facilitated early mobilization

Intervention Type: 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.

Usual care

Instructions about early mobilization covered in a preoperative education session

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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)

Interventions

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.

Intervention Type: OTHER

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)

Intervention Type: OTHER

Other Intervention Names

Early ambulation; Preoperative education

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitacs

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Dr. Liane S. Feldman

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liane S Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

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

Julio F Fiore Junior, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Nancy Mayo, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Franco Carli, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32324693 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27997472 (View on PubMed)

Other Identifiers

Mitacs Elevate Fellowship

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MUHC Study Code 13-329-SDR

Identifier Type: -

Identifier Source: org_study_id