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Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT00490126
Recruitment Status : Recruiting
First Posted : June 22, 2007
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment
Laparoscopy Other: Laparoscopic Surgery Data Collection

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Other
Official Title: Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery in the Department of Gynecologic Oncology
Actual Study Start Date : June 2006
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery. [ Time Frame: 21 Years ]

Secondary Outcome Measures :
  1. Organize clinical information, patient characteristics, treatment, and laparoscopic outcome data into a single data repository, maintained in a secure platform that will provide an archive for future research. [ Time Frame: 21 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490126


Contacts
Contact: Pedro Ramirez, MD 713-563-4569

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Pedro Ramirez, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Pedro Ramirez, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00490126     History of Changes
Other Study ID Numbers: 2006-0170
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Laparoscopic Surgery
Laparoscopy
Gynecology
Demographics
Perioperative Care