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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00671827 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Gynecologic Cancer |
Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology |
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Robotic Gynecologic Surgery
Patients who have undergone or will undergo a robotic-assisted gynecologic procedure.
|
Behavioral: Questionnaire
Questionnaires each taking less than 10 minutes to complete.
Other Name: Survey
|
Information Collection:
If you agree to take part in this study, the following information will be collected from your medical record after 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 M. D. 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.
Additional Information:
Researchers will do the best to ensure that your information is kept confidential, but cannot ensure complete privacy. To help protect confidentiality, participants will be identified by a study specific number, instead of your name. This number will be assigned when you agree to take part in this study. The database that is used to store the information collected about you and your procedure will be password-protected with access limited to study staff. To help further protect your confidentiality, the data sheets (worksheets that are used to collect information before it is entered into the database) will be locked in a filing cabinet in the study chair's office.
This is an investigational study.
Up to 500 patients will take part in this study at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital.
Inclusion Criteria:
1) All women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital are eligible for inclusion in this study. They should be able to speak either English or Spanish.
Exclusion Criteria:
1) None
Contacts and Locations| Contact: Jacalyn Gano, RN | 713-794-1422 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Pamela Soliman, MD | |
| St. Luke's Episcopal Hospital | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Pamela Soliman, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00671827 History of Changes |
| Other Study ID Numbers: | 2008-0122 |
| Study First Received: | April 30, 2008 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Gynecologic Cancer Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Uterine Cancer |
Vaginal Cancer Vulvar Cancer Questionnaire Survey Robot-Assisted Surgery |
