Return to List

Study Summary
No. 2008-0122:.......Cervix; Endometrial; Fallopian Tube; Ovary; Uterus; Vagina; Vulva......Pamela Soliman......Gynecologic Oncology
.
Study Summary Title
Study Summary
Number:		2008-0122
Study Title:Prospective evaluation of robot-assisted surgery in gynecologic oncology
.
Physician New Patient Referral
Name:Pamela SolimanPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-2352
Contact us about clinical trials
.
General Information
Disease Group:Cervix
Endometrial
Fallopian Tube
Ovary
Uterus
Vagina
Vulva		Supported By:N/A
Phase of Study:N/AReturn
Visit:		only for regularly scheduled follow up
Treatment
Agents:		QuestionnaireHome Care:None
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		none
Description/
Intervention:		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.
.
Study Objectives / Outcomes
Primary Objective:
To both retrospectively and prospectively collect data on surgical times, procedures performed, intra-operative and postoperative complications of robot-assisted gynecologic oncology cases performed at MD Anderson and St. Luke's Episcopal Hospital.

Secondary Objectives:
To evaluate surgical times for each portion of a procedure over time for an individual physician as more experience is gained and to evaluate surgical times for fellows in training.

To evaluate quality of life in patients undergoing robotic procedures for gynecologic indications including health and well-being, sexual function, symptom inventory and satisfaction with decision analysis.

To evaluate postoperative pain and nausea management in patients who had robotic surgery compared to laparoscopy (Data obtained through Protocol 2006-0170).
.
Study Status Information
Study Activation / Registration Date:04/29/2008
IRB Review and Approval Date:04/29/2008
Study Type:Observational
Recruitment Status:Open
Projected Accrual:500
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) All women who have undergone or will undergo a robotic-assisted gynecologic procedure at M. D. Anderson Cancer Center and St. Luke's Episcopal Hospital are eligible for inclusion in this study. They should be able to speak either English or Spanish.
Exclusion Criteria:1) None
.
Links
Registration Number: NCT00671827
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center