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Evaluation of Robot-Assisted Surgery in Gynecologic Oncology

NCT ID: NCT00671827

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

588 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-29

Study Completion Date

2020-12-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gynecologic Cancer

Keywords

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Gynecologic Cancer Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Uterine Cancer Vaginal Cancer Vulvar Cancer Questionnaire Survey Robot-Assisted Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Robotic Gynecologic Surgery

Patients who have undergone or will undergo a robotic-assisted gynecologic procedure.

Questionnaire

Intervention Type BEHAVIORAL

Questionnaires each taking less than 10 minutes to complete.

Interventions

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Questionnaire

Questionnaires each taking less than 10 minutes to complete.

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Soliman, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Banner Arizona

Gilbert, Arizona, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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2008-0122

Identifier Type: -

Identifier Source: org_study_id