Evaluation of Robot-Assisted Surgery in Gynecologic Oncology

Gynecologic Cancer Clinical Trial

Official title:

Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671827
• Other study ID #: 2008-0122
• Status: Completed
• Start date: April 29, 2008
• Est. completion date: December 17, 2020

Study information

• Verified date: December 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to collect information about the length of surgery, the procedures performed during surgery, and any possible side effects of robot-assisted gynecologic cancer surgeries. The researchers also want to learn if patients who have robot-assisted surgeries have fewer complications during recovery.

Description:

Information Collection:

If you agree to take part in this study, the following information will be collected from your medical record after surgery:

• The reason you had or are scheduled to have robot-assisted surgery.

• How long the surgery took to complete.

• What procedures were performed during the surgery.

• If cancer was or was not found in the tissue that was removed.

• How long you were in the hospital.

• What complications, if any, happened that are related to the surgery.

Follow-Up Questionnaires:

Depending on when you enroll in the study, you may be asked to complete a short questionnaire 3 different times, each questionnaire will take less than 10 minutes to complete. If you had surgery for cervical cancer, you will complete the questionnaire 2 weeks after surgery. All patients will complete the questionnaires 4-6 weeks after surgery, and again 3-6 months later.

If you have your follow up care with a doctor outside of MD Anderson, you will be called to complete the questionnaires over the phone. Each phone call should last about 10 minutes This questionnaire and/or phone calls will ask questions about any side effects you have experienced that you think may be related to the surgery.

Length of Study:

After the last questionnaire is completed, your participation in the study is over.

This is an investigational study.

Up to 1,000 patients will take part in this study at MD Anderson Cancer Center and Banner MD Anderson Arizona.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1) All women who have undergone or will undergo a robotic-assisted gynecologic procedure at MD Anderson Cancer Center and MD Anderson Banner - Arizona are eligible for inclusion in this study. They should be able to speak either English or Spanish.

Exclusion Criteria:

1) None

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Behavioral:
• Questionnaire
Questionnaires each taking less than 10 minutes to complete.

Locations

Country	Name	City	State
United States	MD Anderson Banner Arizona	Gilbert	Arizona
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	Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases		5 Years

External Links

•   University of Texas MD Anderson Cancer Center Website