Clinical trial NCT00671827: Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
Official title: Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Keywords: Gynecologic Cancer
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Uterine Cancer
Vaginal Cancer
Vulvar Cancer
Questionnaire
Survey
Robot-Assisted Surgery
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-05-05
Enrollment: 588
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital.

Brief summary: The goal of this observational study is to collect information about the length of surgery, the procedures performed during surgery, and any possible side effects of robot-assisted gynecologic cancer surgeries. The researchers also want to learn if patients who have robot-assisted surgeries have fewer complications during recovery.

Detailed description: Information Collection:

If you agree to take part in this study, the following information will be collected from your medical record after surgery:

* The reason you had or are scheduled to have robot-assisted surgery.
* How long the surgery took to complete.
* What procedures were performed during the surgery.
* If cancer was or was not found in the tissue that was removed.
* How long you were in the hospital.
* What complications, if any, happened that are related to the surgery.

Follow-Up Questionnaires:

Depending on when you enroll in the study, you may be asked to complete a short questionnaire 3 different times, each questionnaire will take less than 10 minutes to complete. If you had surgery for cervical cancer, you will complete the questionnaire 2 weeks after surgery. All patients will complete the questionnaires 4-6 weeks after surgery, and again 3-6 months later.

If you have your follow up care with a doctor outside of MD Anderson, you will be called to complete the questionnaires over the phone. Each phone call should last about 10 minutes This questionnaire and/or phone calls will ask questions about any side effects you have experienced that you think may be related to the surgery.

Length of Study:

After the last questionnaire is completed, your participation in the study is over.

This is an investigational study.

Up to 1,000 patients will take part in this study at MD Anderson Cancer Center and Banner MD Anderson Arizona.

Eligibility criteria: Inclusion Criteria:

1) All women who have undergone or will undergo a robotic-assisted gynecologic procedure at MD Anderson Cancer Center and MD Anderson Banner - Arizona are eligible for inclusion in this study. They should be able to speak either English or Spanish.

Exclusion Criteria:

1) None

Primary outcomes:
measure: Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: MD Anderson Banner Arizona
state: Arizona
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Pamela Soliman, MD
role: PRINCIPAL_INVESTIGATOR
References: