Multimodal Prehabilitation for Colorectal Surgery

NCT01356264 | Completed Phase 2

• 1 other identifier: GEN# 11-004
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.

Conditions

Colorectal Cancer; Colorectal Cancer Stage III

Keywords

colorectal cancer; colorectal surgery; prehabilitation; surgical recovery; exercise; referred for scheduled resection

Outcome Measures

Primary Outcomes (1)

• six minute walk test

  6 MWT is a patient-relevant measure of functional walking capacity, reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk. The distance in meters is recorded. Reference equations are available for calculating percent of age- and gender-specific norms.

  baseline, preop, 4 weeks, 8weeks postop

Secondary Outcomes (6)

• Health-related quality of life

  baseline, preop, 4 weeks, 8 weeks

• physical activity level

  baseline, preop, 4 weeks, 8 weeks

• Depression and anxiety

  baseline, preop, 4 weeks, 8 weeks

• nutritional status

  baseline, preop, 4 weeks, 8 weeks

• postoperative complications

  4 weeks

Study Arms (2)

multimodal prehabilitation begun preop

EXPERIMENTAL

The prehabilitation program will begin several weeks preop and continue in the postoperative period

Behavioral: multimodal prehabilitation

Multimodal prehabilitation begun postop

ACTIVE COMPARATOR

The prehabilitation program will begin after the surgery.

Behavioral: multimodal prehabilitation

Interventions

multimodal prehabilitation BEHAVIORAL

multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support starting 3-5 weeks before surgery and continuing postoperative for up to 8 weeks

multimodal prehabilitation begun preop

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• referred for scheduled surgery for nonmetastasized colorectal cancer
• age \> 18 years old

You may not qualify if:

• asa 4-5
• Poor English or French comprehension
• severe co-morbid disease interfering with ability to perform exercise at home or complete testing

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Society of American Gastrointestinal and Endoscopic Surgeons: collaborator
• Immunotec Inc.: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (4)

• Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.

  PMID: 37162250 DERIVED

• Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.

  PMID: 35588252 DERIVED

• Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.

  PMID: 30025745 DERIVED

• Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

  PMID: 23052535 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: May 17, 2011
• First Posted: May 19, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

CA (1)