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Evaluation of Robot-Assisted Surgery in Gynecologic Oncology

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ClinicalTrials.gov Identifier: NCT00671827
Recruitment Status : Active, not recruiting
First Posted : May 5, 2008
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Gynecologic Cancer Behavioral: Questionnaire

Detailed 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.


Study Design

Study Type : Observational
Actual Enrollment : 588 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology
Actual Study Start Date : April 29, 2008
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


Groups and Cohorts

Group/Cohort Intervention/treatment
Robotic Gynecologic Surgery
Patients who have undergone or will undergo a robotic-assisted gynecologic procedure.
Behavioral: Questionnaire
Questionnaires each taking less than 10 minutes to complete.
Other Name: Survey


Outcome Measures

Primary Outcome Measures :
  1. Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases [ Time Frame: 5 Years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital.
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671827


Locations
United States, Arizona
MD Anderson Banner Arizona
Gilbert, Arizona, United States, 85234
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Pamela Soliman, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00671827     History of Changes
Other Study ID Numbers: 2008-0122
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Keywords provided by M.D. Anderson Cancer Center:
Gynecologic Cancer
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Uterine Cancer
Vaginal Cancer
Vulvar Cancer
Questionnaire
Survey
Robot-Assisted Surgery