Enhancing Outcomes After Colon Surgery

This study has been completed.
Sponsor:
Collaborator:
Canadian Anesthesiologists' Society
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT00227526
First received: September 27, 2005
Last updated: September 2, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Colorectal Surgery
Behavioral: Prehabilitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Enhancing Outcomes After Colon Surgery: Role of Prehabilitation Facilitating the Recovery Process.

Further study details as provided by McGill University:

Primary Outcome Measures:
  • 6 Minute Walk Test [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • V02 max and submax [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
  • SF-36 - Short form 36 [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • CHAMPS - Community Healthy Activities Model Program for Seniors [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety Depression Scale - HADS [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Fatigue and Pain VAS [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Visual Analogue Mood States (VAMS) [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • 2Minute Walk Test [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Complications: infection (wound, sepsis, urinary, lung); bleeding; wound dehiscence; technical complications (ileus, anastomotic leakage); stroke, MI, DVT/PE, delirium, fall w/wo injury; malnutrition; urinary retention; respiratory failure [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Charges for bed day: surgical procedure; surgeon/anaesthesiologist; pre, post and follow-up tests and procedures; visits; follow-up medications [ Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The surgical process is a major stressor because of the psychological distress, tissue trauma, lack of activity, and quasi-starvation and it produces immediate systemic changes and both short- and long-term effects on activity and quality of life. However, there is mounting evidence that many of the negative immediate effects of surgery such as pain, fatigue, and weakness are amenable to intervention. If proper interventions are carried out, these symptoms may be readily controlled allowing for a faster recovery and early home discharge. But the effects of surgery are felt far beyond the immediate convalescent period and patients can feel fatigued for many weeks and this delays return to usual function and reduces quality of life. Thus, it would be of great practical benefit if ways of improving post-surgery physical function and quality of life could be identified.

Traditionally efforts have been made to improve the recovery process by intervening in the post-operative period. However, the post-operative period may not be the most opportune time to introduce interventions to accelerate recovery. Many of these surgical patients are concerned about perturbing the healing process as well as being depressed and anxious if they await further treatment. The pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor has been termed prehabilitation The purpose of this study is to address the following research question: Among persons scheduled for colorectal surgery, does a pre-operative program of aerobic and muscle strength training (prehabilitation) compared to a standard peri-operative educational protocol affect functional exercise capacity and health-related quality of life? The trial will be a single blind, stratified (on cancer diagnosis or not), randomized, two-group (prehabilitation or standard care), parallel design. Both groups will receive the same peri-operative education program. In conformity with current practice, all subjects will also be advised on nutritional support during the preoperative period. Persons with albumin < 38 gm./l will receive an adequate supply of protein and calorie nutritional supplement bars. In addition to this standard care, the prehabilitation group will be prescribed a program of exercise training consisting of daily stationary cycling from the start of the intervention to the day prior to surgery (minimum 3 weeks) combined with an individualized program of muscle strength training.

Both groups will be evaluated for exercise tolerance, walking capacity and health and emotional status at enrolment and after 3 three weeks of training as well as at 4 weeks, 8 weeks and 24 weeks (6 months) post-surgery. The main outcome measure will be the 6 Minute Walk Test - a valid and reliable measure of functional walking capacity. The estimator of effect will be the proportion of people in each group who, at 8 weeks post-surgery, achieve or exceed their baseline value on this test (± 20m). The proposed sample size is 200. This is based on 80% power to detect a difference of 22% in the proportion recovering to baseline values (40% in standard and 62% in prehabilitation). 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227526

Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University
Canadian Anesthesiologists' Society
Investigators
Principal Investigator: Francesco Carli, MD McGill University Health Center
Principal Investigator: Nancy Mayo, PhD McGill University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00227526     History of Changes
Other Study ID Numbers: REC02-053
Study First Received: September 27, 2005
Last Updated: September 2, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:
Colon
Surgery
Prehabilitation
Exercise

ClinicalTrials.gov processed this record on September 16, 2014