Choosing Different Procedures For Tubal Sterilization
Purpose of the study
The purpose of this study is to see if the tubes can be removed safely in women have decided to have their tubes tied for birth control. New guidelines state that women who want to have their tubes tied (official name is tubal ligation) to prevent future pregnancies should consider having their tubes completely removed rather than tied.
The reason for this new recommendation is that completely removing your tubes may decrease your chances of ever developing ovarian cancer. Your lifetime risk of having ovarian cancer is 1.7%
What Does This Study Involve?
Once you agree to be in this study, you will have a procedure so that you cannot become pregnant again. By
TUBAL STUDY
Study Team:
XXX, XXXXX MD (Team Leader) XXXXX, XXXXX MD
XXX XXX-XXXX MD XXXX XXXXX MD XXXXXXX XXX MD
XXXX XXXX Coordinator
Important phone number!!
UNC Research Staff
XXX-XXX-XXXX
agreeing to participate in this study, you will be given the choice to proceed with the normal procedure to tie your tubes OR you may choose to have both of your tubes completely removed.
If you agree to participate, you will tell your doctor which type of tubal procedure you wish to have: normal tubes tied (tubal ligation) OR complete tubal removal. Study staff will record information about you, your medical history, and details about your surgery when it happens.
A study team member will call you at 1 and 6 weeks after you are discharged from the hospital to ask you how you feel, to see if you have had any problems, or if you have seen a doctor or been readmitted to the hospital since your surgery. It is very important that we can contact you, so you will provide phone numbers, email and other contact information.
What Are the Risks of This Study?
You have decided to have your tubes tied. If you choose to have the normal tube tying procedure, the risks will be no different because of participating in this study. Your doctor will review those risks with you.
If you choose to have your tubes completely removed, you may experience an increased risk from the surgery. It is unknown if the risks are increased, and by how much. There may be increased risk for bleeding or damage to other
organs, or longer surgery time. We estimate that the risk of having a complication from complete tubal removal is between 1 and 4%; the risk from a complication from a standard tubal ligation is <2%.
Both procedures are permanent. There is a risk for
“regret” following sterilization tube tying procedure, but less than 2% of women over the age of 30 have regret.
Complete tubal removal is not reversible. If you choose to have your tubes completely removed and you have regret later in life, the only option for future pregnancy is in-vitro fertilization. You should not have a either procedure if you are not completely sure that you are done having children.
There are other possible risks that are listed in the consent form and will be discussed with you before you agree to participate.
Will This Study Help Me?
We do not know if being in this study will help you, but you may have less chance of ovarian cancer later in life if you choose to have your tubes completely removed. In addition, this study may help other women in the future.
What do I do if I want to participate?
Tell your doctors, study staff, or call the research staff phone number if you want to learn more about the study.
