A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
18 Years
N/A
Both
Abdominal Cancer, Pelvic Cancer
Trial Information
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
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.
Inclusion Criteria:
1. Patient 18 years of age or older.
2. Patients 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).
3. Patients who have signed the consent form to participate in the study.
4. Patients must have been evaluated in the Preanesthesia Clinic or by a staff
Anesthesiologist preoperatively.
5. All laboratory and diagnostic evaluations required or used to evaluate the patient in
the Preanesthesia Clinic must be completed. All patients must be approved for surgery
by the standards of the Preanesthesia Clinic.
Exclusion Criteria:
1. Patient under age 18
2. Patient is unwilling to sign consent.
3. Patient is unable to exercise. (Bedridden or wheel chair bound)
4. Patient is enrolled in another study deemed by the investigator to affect oxygen
metabolic efficiency and not presently the standard of care at MDACC.
5. Any patient whose condition is deemed unsatisfactory for surgery after the
preanesthetic evaluation. The patient may reenter the study after reevaluation in the
Preanesthesia Clinic and is determined suitable for surgery.
6. Surgery canceled for any reason. The patient may reenter the study if surgery is
rescheduled.
7. Patient has had a myocardial infarction within 3 month of visiting the Preanesthesia
Clinic or presents with new or unstable angina
8. Patient has a history of a cerebrovascular accident or transit ischemic attacks
within 3 month of visiting the Preanesthesia Clinic.
9. Patient has a history of a pulmonary embolic event within 3 month of visiting the
Preanesthesia Clinic.
10. Patient known to have acute or chronic deep vein thrombosis.
11. Pregnant patients.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Patient Perioperative Risk + Postoperative Morbidity
Outcome Time Frame:
Baseline + 30 days postoperatively monitoring for morbid events
Safety Issue:
No
Principal Investigator
Curtis E. Hightower, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0303
NCT ID:
NCT00493688
Start Date:
October 2005
Completion Date:
Related Keywords:
- Abdominal Cancer
- Pelvic Cancer
- Abdominal Cancer
- Pelvic Cancer
- Perioperative Energy Dynamics
- Cardiopulmonary Exercise Testing
- CPET
- Abdominal Neoplasms
- Pelvic Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
