A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
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|ClinicalTrials.gov Identifier: NCT00493688|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2007
Last Update Posted : January 9, 2018
To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.
In this proposed study researchers will:
- Measure preoperative energy reserve capacity (fitness)
- Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism
|Condition or disease||Intervention/treatment|
|Abdominal Cancer Pelvic Cancer||Other: Cardiopulmonary Exercise Testing (CPET)|
Participants in this study are already scheduled to have major abdominal or pelvic cancer surgery.
If you agree to take part in this study, you will exercise on a stationary bicycle, while breathing through a mouthpiece and wearing a nose clip, before your surgery. You will be asked to pedal at 60 revolutions per minute as the resistance to pedaling gradually increases. During your pedaling, your vital signs will be monitored using a blood pressure cuff, electrocardiogram (ECG) leads (to measure the electrical activity of the heart), and a pulse oximeter. The mouthpiece is used to analyze the inhaled vs the exhaled breaths. The nose clip is to remind you to breathe through the mouthpiece. This will help researchers learn the level of oxygen uptake during exercise, before surgery.
You will stop the test when you become tired. The length of this test will vary from participant to participant.
You will be asked questions to help rate how well you are able to move physically, based on two independent forms. These forms will rate your physical status according to 2 scales ( 0 to 4, and 10 to 100, respectively), with high scores meaning less difficulty with physical movement and lower scores meaning you have more difficulty with physical movement.
You will be asked to complete a brief form asking 12 questions on your ability to perform activities of daily living. Examples include; Can you take care of yourself? Can you climb a flight of stairs? You will also be contacted by telephone at 30 days, 6 months, 1 year, and 2 years after your surgery and asked the same 12 questions. If we are unable to reach you by telephone, the questionnaire will be mailed to your home with a return, postage paid envelope included. It should take about 5 minutes to complete. Once you have completed the 2-year questionnaire, your participation in this study will be over.
THIS IS AN INVESTIGATIONAL STUDY. Between 180-200 patients per surgical group will take part in this study. All will be enrolled at M. D. Anderson.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes|
|Actual Study Start Date :||October 2005|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
|Cardiopulmonary Exercise Testing (CPET)||
Other: Cardiopulmonary Exercise Testing (CPET)
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
- Patient Perioperative Risk [ Time Frame: Baseline + 30 days postoperatively monitoring for morbid events ]Measure preoperative energy reserve capacity (fitness) using perioperative energy dynamics where fitness is defined by gas exchange data during cardiopulmonary exercise testing as method of assessing perioperative risk
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493688
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anh Dang, MD||M.D. Anderson Cancer Center|