Longitudinal Evaluation of Women Undergoing Pelvic Exenteration for Treatment of Gynecologic Malignancy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational

The study investigates whether certain characteristics of gynecological cancer can help researchers predict how well a patient recovers from surgery to remove the lower colon, rectum, and bladder, and create openings through which urine and stool are passed out of the body (pelvic exenteration). Comparing the types of surgery completed and procedures used may help researchers to determine which are most effective and safe in patients with a history of gynecologic cancer.

Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No

• Women with a history of gynecologic malignancy, including cervical, endometrial, vulvar, or vaginal carcinoma of any histology

• Women who have undergone a pelvic exenteration after January 1993 or who are being offered a pelvic exenteration for treatment of their gynecologic malignancy

• Patients must be suitable candidates for surgery (in case of prospective collection)

• Patients who have signed an approved informed consent

• Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease

• Women must be able to read and write in either Spanish or English

United States
M D Anderson Cancer Center
Contact Information
Pamela Soliman
Time Frame
Start Date: July 11, 2008
Estimated Completion Date: September 30, 2025
Target number of participants: 200
Observational (questionnaires)
RETROSPECTIVE PORTION: Patients who have undergone pelvic exenteration complete one set of QOL questionnaires.~PROSPECTIVE PORTION: Patients undergoing pelvic exenteration complete questionnaires over 20-40 minutes within 2 weeks before surgery, and at 4-12 weeks, 6 months, and 1, 2, 3, 4, 5, and 10 years after surgery regarding feelings, abilities, depression, coping, social support, sexual function and body image. Patients with cervical cancer may complete 1 additional questionnaire during each of these visits.
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov

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