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NCT00490126 Clinical Trial

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

Laparoscopy Clinical Trial

Official title:
Data Collection of Demographics and Perioperative Care of Patients Undergoing Laparoscopic Surgery in the Department of Gynecologic Oncology

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00490126
Other study ID # 2006-0170
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 15, 2006
Est. completion date September 18, 2018

Study information
Verified date January 2019
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 31
Est. completion date September 18, 2018
Est. primary completion date September 18, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery. 21 Years
Secondary 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. 21 Years
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