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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00490126 |
Purpose
The goal of this clinical research study is to collect information on patients who had or are going to have laparoscopy performed at M. D. Anderson. Researchers want to use this information to learn the effects of laparoscopic surgery on patients over time.
| Condition | Intervention |
|---|---|
|
Laparoscopy |
Other: Laparoscopic Surgery Data Collection |
| Study Type: | Observational |
| Official Title: | Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery in the Department of Gynecologic Oncology |
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | June 2027 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Laparoscopic Surgery Database |
Other: Laparoscopic Surgery Data Collection
Prospectively and retrospectively collect data on patients who had laparoscopic surgery since January 1, 1990 forward. Data from the initial patient visit note, consultation notes, operative report, discharge summary, and follow-up progress notes will be entered into the database.
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If you agree to take part in this study, your demographic information (such as your age, race, medical and surgical history, and type of cancer) will be collected. Information about the type of surgical procedure performed on you, your care during and after your surgery, any problems related to your surgery, and details about your follow-up care will be entered into a research database. This information will be collected from patients seen at M. D. Anderson since January 1, 1990. It will be used for future research studies.
The research database will be updated, after about 1 year, to include information on your disease outcome, treatment, and/or follow-up care. This information will be collected from your medical record, if possible. If it is not in your medical record, you may again be contacted so that researchers can learn this information.
Your participation in this study will continue up to 5 years after your laparoscopic procedure.
This is an investigational study. Up to 1,000 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All patients who had or will have laparoscopic surgery in the Department of Gynecologic Oncology (Gynecologic Oncology and General Gynecology) since January 1, 1990 forward.
Inclusion Criteria:
1. All patients who had or will have laparoscopic surgery in the Department of Gynecologic Oncology (Gynecologic Oncology and General Gynecology) since January 1, 1990 forward.
Exclusion Criteria: None
Contacts and Locations| Contact: Pedro Ramirez, MD | 713-563-4569 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Pedro Ramirez, MD | |
| Principal Investigator: | Pedro Ramirez, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Pedro Ramirez, MD/Associate Professor ) |
| Study ID Numbers: | 2006-0170 |
| Study First Received: | June 20, 2007 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00490126 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Laparoscopic Surgery Laparoscopy Gynecology Demographics Perioperative Care |