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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00490126
First received: June 20, 2007
Last updated: May 5, 2014
Last verified: May 2014

June 20, 2007
May 5, 2014
June 2006
June 2027   (final data collection date for primary outcome measure)
Collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery. [ Time Frame: 21 Years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00490126 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery
Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery in the Department of Gynecologic Oncology

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.

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.

Observational
Not Provided
Not Provided
Not Provided
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.

Laparoscopy
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.
Laparoscopic Surgery Database
Intervention: Other: Laparoscopic Surgery Data Collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
Not Provided
June 2027   (final data collection date for primary outcome measure)

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

Female
Not Provided
No
Contact: Pedro Ramirez, MD 713-563-4569
United States
 
NCT00490126
2006-0170
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Pedro Ramirez, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP