None listed
Conditions
Brief summary
To establish the potential harms or benefits of performing a prophylactic ovariectomy in conjunction with a hysterectomy in postmenopausal women. The objectives are: to disprove the following null hypothesis’s 1. The well-being and the quality of life of post menopausal women shall not be adversely affected in those who have a hysterectomy in conjunction with ovariectomy compared to those who have a hysterectomy alone. 2. The requirement for further pelvic surgical intervention in post menopausal women who have a hysterectomy in conjunction with ovariectomy is not greater compared to those who have a hysterectomy alone.
Interventions
The term prophylactic ovariectomy implies that the ovaries are normal at the time of the hysterectomy and that it is performed for possible future benefit.
Usually the decision to remove or preserve the ovaries is based on the surgeon’s recommendations or by request of the patient. Many clinics say that 45 years old is the age at which a prophylactic ovariectomy is strongly recommended. Also, the predominant teaching is that a prophylactic ovariectomy in patients with low risk of ovarian cancer
The term prophylactic ovariectomy implies that the ovaries are normal at the time of the hysterectomy and that it is performed for possible future benefit. Usually the decision to remove or preserve the ovaries is based on the surgeon’s recommendations or by request of the patient. Many clinics say that 45 years old is the age at which a prophylactic ovariectomy is strongly recommended. Also, the predominant teaching is that a prophylactic ovariectomy in patients with low risk of ovarian cancer must be avoided in women under 40 years old. It is routinely performed in women over 50 years old and is individualized in between. Data gathered from the Centers for Disease Control and Prevention in the United States in between the years of 1988 and 1993, reported that ovarian retention only happens in about 40% to 50% of the patients who undergo a hysterectomy at the age of 40 or more. Conservative numbers suggest that about 300,000 women suffer from bilateral prophylactic ovariectomy each year in the same country. In this trial, intervention group will undergo a hysterectomy without bilateral ovariectomy while the control group will have a bilateral ovariectomy (current clinical practice) during the hysterectomy.
Sponsors
The International Health Central American Institute Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
A woman will be eligible for inclusion in this study only if all of the following criteria apply 1 Women about to have an elective hysterectomy for benign causes shall be considered. 2. Woman has provided written informed consent to participate in the study.
Exclusion criteria
A woman will not be eligible for inclusion in this study if any of the following criteria apply. 1. The woman is currently participating or has participated in an investigational trial during the previous four months 2. The woman in the judgment of the principal investigator, is unlikely to be able to be prospectively followed for a five year period 3. The woman has a previous family history of first grade ovarian cancer 4. The woman has antecedents of psychiatric disease and the use of psychotropic drugs. 5. The woman requires a hysterectomy due to the presence of neoplasia.
Outcome results
None listed