NCT00490126

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

12.3 years

First QC Date

June 20, 2007

Last Update Submit

January 11, 2019

Conditions

Laparoscopy

Keywords

Laparoscopic SurgeryLaparoscopyGynecologyDemographicsPerioperative Care

Outcome Measures

Primary Outcomes (1)

  • Collect, both prospectively and retrospectively, data on demographics, perioperative care, and patient outcomes in patients undergoing laparoscopic surgery.

    21 Years

Secondary Outcomes (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.

    21 Years

Study Arms (1)

Laparoscopic Surgery Database

Other: Laparoscopic Surgery Data Collection

Interventions

Laparoscopic Surgery Data CollectionOTHER

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Study Officials

  • Pedro Ramirez, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

June 15, 2006

Primary Completion

September 18, 2018

Study Completion

September 18, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

US(1)