Early Mobilization After Colorectal Surgery

NCT02131844 | Completed

• 2 other identifiers: MUHC Study Code 13-329-SDRMitacs Elevate Fellowship
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases; Rectal Diseases

Keywords

colorectal surgery; postoperative recovery; early mobilization

Outcome Measures

Primary Outcomes (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)

  before surgery; 4 weeks after surgery

Secondary Outcomes (10)

• Time out of bed (sitting and standing)

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

• Time to readiness for discharge

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

• Time to recovery of gastrointestinal motility

  Expected average of 2 days after surgery

• Postoperative fatigue (Multidimensional Fatigue Inventory)

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

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

  before surgery; 2 weeks after surgery; 4 weeks after surgery

Study Arms (2)

Facilitated early mobilization

EXPERIMENTAL

Early mobilization facilitated by a dedicated health professional

Other: Facilitated early mobilization

Usual care

ACTIVE COMPARATOR

Instructions about early mobilization covered in a preoperative education session

Other: Usual care

Interventions

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.

Also known as: Early ambulation

Facilitated early mobilization

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)

Also known as: Preoperative education

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Mitacs: collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (2)

• 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.

  PMID: 32324693 DERIVED

• 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.

  PMID: 27997472 DERIVED

MeSH Terms

Conditions

Colonic Diseases; Rectal Diseases

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Liane S Feldman, MD

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

  PRINCIPAL INVESTIGATOR

• Julio F Fiore Junior, PhD

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

  PRINCIPAL INVESTIGATOR

• Nancy Mayo, PhD

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

  PRINCIPAL INVESTIGATOR

• Franco Carli, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: May 6, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: May 1, 2016
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

CA (1)