Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00490126

Purpose

To collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery in the Department of Gynecologic Oncology.
To 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.

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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
1 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.

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 information about your cancer and treatment will mostly come from your M. D. Anderson medical record. However, some information may also be requested from you, your home physician, or an outside hospital. The information that is received from places other than M. D. Anderson will be included in your M. D. Anderson medical record and this study-related research database. You may be contacted by research staff if researchers have additional questions of you, or if information in your outside medical records is not complete or does not match what is in your M. D. Anderson medical record.

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.

Before your information can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of M. D. Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at M. D. Anderson, including research involving your information, must first be approved by the IRB.

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490126

Contacts

Contact: Pedro Ramirez, MD

713-563-4569

Locations

United States, Texas
U.T.M.D. 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

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

U.T. MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

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:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00490126 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Laparoscopic Surgery
Laparoscopy
Gynecology
Demographics
Perioperative Care

ClinicalTrials.gov processed this record on July 02, 2009