Abdominal Cancer Clinical Trial
Official title:
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Verified date | May 2019 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To validate a new method for assessing perioperative risk in the cancer patient undergoing
major cancer surgery.
In this proposed study researchers will:
1. Measure preoperative energy reserve capacity (fitness)
2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas
exchange metabolism
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Perioperative Risk | 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 | Baseline + 30 days postoperatively monitoring for morbid events |
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