Evaluation of Robot-Assisted Surgery in Gynecologic Oncology

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00671827
First received: April 30, 2008
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention
Gynecologic Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Prospective Evaluation of Robot-Assisted Surgery in Gynecologic Oncology

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Data Collection of Surgical Times, Procedures Performed, Intra-operative + Postoperative Complications of Robot-assisted Gynecologic Oncology Cases [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2008
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671827

Contacts
Contact: Jacalyn Gano, RN 713-794-1422

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Pamela Soliman, MD         
St. Luke's Episcopal Hospital Recruiting
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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00671827     History of Changes
Other Study ID Numbers: 2008-0122
Study First Received: April 30, 2008
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014