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Colorectal SurgeryPhase 2NCT00227526

Enhancing Outcomes After Colon Surgery

A Phase 2 study testing Prehabilitation in people with Colorectal Surgery, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Surgery
What is being tested?
Prehabilitation
How many people
200 participants
Where
1 siteCanada
Study dates
Feb 2005to Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

Official title: Enhancing Outcomes After Colon Surgery: Role of Prehabilitation Facilitating the Recovery Process.

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.

Read the 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.

Being tested
Prehabilitation
Keywords
Colon, Surgery, Prehabilitation, Exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrehabilitationBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Minute Walk Test

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

Secondary outcomes (9)
  1. V02 max and submax

    Measured: baseline, 24 weeks

  2. SF-36 - Short form 36

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

  3. CHAMPS - Community Healthy Activities Model Program for Seniors

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

  4. Hospital Anxiety Depression Scale - HADS

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

  5. Fatigue and Pain VAS

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

  6. Visual Analogue Mood States (VAMS)

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

  7. 2Minute Walk Test

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

  8. 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

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

  9. Charges for bed day: surgical procedure; surgeon/anaesthesiologist; pre, post and follow-up tests and procedures; visits; follow-up medications

    Measured: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00227526
Sponsor's protocol ID
REC02-053
Status last verified
Sep 2010
First submitted
27 Sep 2005
Last updated
6 Sep 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11878719
  • 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.

    PubMed 10370832
  • 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.

    PubMed 12218518
  • 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.

    PubMed 21878237
  • 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.

    PubMed 20602503

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prehabilitation in people with Colorectal Surgery, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minute Walk Test (time frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00227526, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2010.

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