Clinical Trial: The Women Choosing Surgical Prevention (WISP) Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: WISP (Women Choosing Surgical Prevention)

Brief Summary:

The goal of this clinical research study is to compare the changes in female sexual function between patients having interval salpingectomy with delayed oophorectomy (ISDO) with those having risk-reducing salpingo-oophorectomy (RRSO) in women who carry genetic mutations. Researchers also want to learn how these surgeries affect your quality of life.

RRSO is the standard surgery for patients with certain types of genetic mutations, where the fallopian tubes and ovaries are removed at the same time.

ISDO is surgery to remove the fallopian tubes first, then the ovaries are removed during a second, later surgery. Most women with genetic mutations will be encouraged to remove the ovaries around the ages of 40 to 50. The decision in timing to remove your ovaries will be made with your doctor.


Detailed Summary:

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned a study arm based on the type of surgery you choose with your doctor. If you choose ISDO, you will be in Group 1. If you choose RRSO, you will be in Group 2.

Group 1:

Surgery #1: Interval Salpingectomy (IS):

If you are in Group 1, the study doctor will discuss the salpingectomy surgery with you in detail, including the risks and possible benefits. You will be asked to sign a surgical consent form.

Most patients have salpingectomy performed as an outpatient procedure. This means that you will likely go home the day of your surgery. If the study doctor plans to have you stay overnight in the hospital for any reason, it will be discussed with you.

During the surgery, the inside of your abdomen will be looked at and both of your fallopian tubes will be removed. If the study doctor finds anything during the surgery that may be cancerous, a tissue sample or a complete ovary will be removed during surgery and tested. If cancer is found, a gynecologic oncologist would perform your cancer surgery.

Post-Salpingectomy (IS) Follow-Up:

One (1) month (+/- 1 month) after surgery:

  • If the doctor thinks it is needed, you may have a physical exam, including an exam of your surgical incisions (wounds) and a review of any complications you may have had from surgery. If you do not live near the hospital, this may be done by a local doctor. If you are unable to visit a your stu
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome:

    • Change in Sexual Function in Interval Salpingectomy with Delayed Oophorectomy (ISDO) Participants [ Time Frame: Baseline to 6 months after interval salpingectomy ]
      Change in sexual function measured by Female Sexual Function Index (FSFI). A change of 4 points is considered to be clinically meaningful.
    • Change in Sexual Function in Risk-Reducing Salpingo-Oophorectomy (RRSO) Participants [ Time Frame: Baseline to 6 months after bilateral salpingo-oophorectomy ]
      Change in sexual function measured by Female Sexual Function Index (FSFI). A change of 4 points is considered to be clinically meaningful.


    Original Primary Outcome:

    • Change in Sexual Function [ Time Frame: Baseline to 6 months after interval salpingectomy ]
      Change in sexual function measured by Female Sexual Function Index (FSFI). A change of 4 points is considered to be clinically meaningful.
    • Change in Sexual Function [ Time Frame: Baseline to 6 months after bilateral salpingo-oophorectomy ]
      Change in sexual function measured by Female Sexual Function Index (FSFI). A change of 4 points is considered to be clinically meaningful.


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: May 2, 2016
    Date Started: May 2016
    Date Completion:
    Last Updated: January 31, 2017
    Last Verified: January 2017