- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00671827
Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Arizona
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Gilbert, Arizona, United States, 85234
- MD Anderson Banner Arizona
-
-
Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Robotic Gynecologic Surgery
Patients who have undergone or will undergo a robotic-assisted gynecologic procedure.
|
Questionnaires each taking less than 10 minutes to complete.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases
Time Frame: 5 Years
|
5 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pamela Soliman, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2008-0122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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