MDACC Study Summary 2005-0303

Study Summary
No. 2005-0303:.......Advanced Cancers......Curtis E. Hightower......Anesthesiology

Study Summary Title



Study Summary Number:	2005-0303

Study Title:	A Study to determine whether Perioperative Energy Dynamics correlates with Postoperative Outcomes

Physician

New Patient Referral



Name:	Curtis E. Hightower	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Anesthesiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2129 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	n/a

Treatment Agents:	None	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to see if cardiopulmonary exercise testing (CPET) is a more accurate method than what is currently being used to predict the outcome of surgical patients who are scheduled for major abdominal or pelvic cancer surgery.

Study Objectives / Outcomes

To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery. In this proposed study we will:
1) Measure preoperative energy reserve capacity (fitness)
2) Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism

Study Status Information



Study Activation / Registration Date:	10/31/2005

IRB Review and Approval Date:	06/01/2005

Study Type:	Cancer Control

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient 18 years of age or older.

2) Patients scheduled for elective major intraabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cystectomy, radical transabdominal debulking with or without intraabdominal 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.

6)

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.

Links

Registration Number: NCT00493688
Study Information on Clinical Trials Registry (clinicaltrials.gov)