Enhancing Outcomes After Colon Surgery

NCT00227526 | Completed Phase 2

• 1 other identifier: REC02-053
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Most patients find that recovering from surgery is difficult particularly after abdominal surgery for cancer or other intestinal disorders. The surgical stress, healing process and concerns if further treatments are required suggest that the post-operative period may not be the best time to get people to exercise to rehabilitate lost functions. Prehabilitation is the process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor, such as surgery, and this study aims to evaluate the effectiveness of prehabilitation for colorectal surgery. Two groups will be formed by a random process and the prehabilitation group will use an exercise cycle and weights to build endurance and strength for a 3-week period prior to surgery. The other group will receive training about exercises that will help them move better after surgery. People who are malnourished prior to surgery will receive nutritional supplements. The results of this trial will be used to inform practitioners and patients alike of the benefits (or risks if any) of exercise in preparing for surgery.

Conditions

Colorectal Surgery

Keywords

Colon; Surgery; Prehabilitation; Exercise

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test

  baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

Secondary Outcomes (9)

• V02 max and submax

  baseline, 24 weeks

• SF-36 - Short form 36

  baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

• CHAMPS - Community Healthy Activities Model Program for Seniors

  baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

• Hospital Anxiety Depression Scale - HADS

  baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

• Fatigue and Pain VAS

  baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

Interventions

Prehabilitation BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• Age 18 and above
• Referred electively for colorectal resection for benign (polyposis adenoma diverticulitis) or non-disseminated colon and rectum cancers
• Referred electively for colorectal resection for colon reconstruction for non-active inflammatory bowel disease
• Referred electively for colorectal resection for fibrostenotic conditions that are a feature of Crohn's disease.

You may not qualify if:

• People with American Society of Anesthesiologists health status class 4-5
• Co-morbid medical conditions interfering with the ability to participate in either group or complete the testing procedures (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
• Patients at high risk for a cardiac complication during exercise at home: severe aortic stenosis, cardiac failure Class IV NYHA, myocardial infarction within 6 months, congestive heart failure, and unstable angina
• Persons with sepsis; and treatment with chemotherapy or radiotherapy during six months prior to the date of surgery
• Those with very low exercise tolerance (\<3.5 METS) as determined by the baseline exercise test
• Anyone with a cardiac arrhythmia that manifests during the baseline exercise testing, prior to randomization
• Those people who are already in excellent physical condition owing to a regular participation in a high intensity physical activity. On testing, persons whose age-predicted value on the 6MWT exceeds 130% will be excluded (expected \<10%)

Sponsors & Collaborators

• McGill University: lead
• Canadian Anesthesiologists' Society: collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (5)

• Carli F, Mayo N. Measuring the outcome of surgical procedures: what are the challenges? Br J Anaesth. 2001 Oct;87(4):531-3. doi: 10.1093/bja/87.4.531. No abstract available.

  PMID: 11878719 BACKGROUND

• Carli F. Perioperative factors influencing surgical morbidity: what the anesthesiologist needs to know. Can J Anaesth. 1999 May;46(5 Pt 2):R70-9. doi: 10.1007/BF03013183. No abstract available. English, French.

  PMID: 10370832 BACKGROUND

• Carli F, Mayo N, Klubien K, Schricker T, Trudel J, Belliveau P. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002 Sep;97(3):540-9. doi: 10.1097/00000542-200209000-00005.

  PMID: 12218518 BACKGROUND

• Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.

  PMID: 21878237 DERIVED

• Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.

  PMID: 20602503 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Francesco Carli, MD

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

  PRINCIPAL INVESTIGATOR

• Nancy Mayo, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 28, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 6, 2010

Record last verified: 2010-09

Locations

CA (1)