A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | June 27, 2007 | ||||
Last Updated Date | June 25, 2012 | ||||
Start Date ICMJE | October 2005 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Patient Perioperative Risk + Postoperative Morbidity [ Time Frame: Baseline + 30 days postoperatively monitoring for morbid events ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Measure preoperative energy reserve capacity (fitness). [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00493688 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE |
Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism. [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes | ||||
Official Title ICMJE | A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes | ||||
Brief Summary | To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery. In this proposed study researchers will:
|
||||
Detailed Description | 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 ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
Biospecimen | |||||
Sampling Method | Probability Sample | ||||
Study Population | Individuals scheduled for elective major intrabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cystectomy, radical transabdominal debulking with or without intrabdominal hyperthermic perfusion, pelvic exenteration, retroperitoneal lymph node dissections, and low anterior resection). |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Other: Cardiopulmonary Exercise Testing (CPET)
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases. |
||||
Study Group/Cohort (s) | Cardiopulmonary Exercise Testing (CPET)
Intervention: Other: Cardiopulmonary Exercise Testing (CPET) |
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 200 | ||||
Completion Date | |||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493688 | ||||
Other Study ID Numbers ICMJE | 2005-0303 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |