Adenomyosis, Endometriosis, Cervical Dysplasia, Dysfunctional Uterine Bleeding, Genital Diseases, Female, Hysterotomy; Affecting Fetus, Leiomyomata Uteri, Uterine Prolapse
Conditions
Brief summary
The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.
Detailed description
Hysterectomy is one of the most common gynecologic procedures performed in clinical practice. In this study we focused on non menopausal patients under 52 years having hysterectomies for benign disease : uterine leiomyomas, adenomyosis, endometriosis, dysfunctional uterine bleeding, genital prolapse, cervical dysplasia... with failure of conservative treatment. the standard procedure during hysterectomy with conservation of the ovaries has been the preservation of fallopian tubes with the clamps placed as close to the uterine corpus as possible. this is suggested to decrease interference with the vascular structures in the mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube, theoretically, these cases could be prevented if tubal excision is performed during hysterectomy The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life. impact of treatments on ovarian reserve are tested by measuring AMH at baseline and 3 days, 6 weeks and 6, 12 months after surgeries. quality of life is also assessed at these time points, with a questionnaire (Women Health Questionnaire WHQ).
Interventions
PROCEDUREconservative hysterectomy I
conservative hysterectomy for benign disease
PROCEDUREConservative hysterectomy II
bilateral salpingectomy during hysterectomy without conservation of the ovaries
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years and less than 52 years * indication of a conservative hysterectomy for benign disease * signed informed consent * non menopausal women (AMH \>0,21 ng/ml)
Exclusion criteria
* pregnancy * desire of future pregnancy * menopausal status * patient unable to give informed consent * any physical or psychiatric condition that could impair with patient's ability to cooperate with post operative data collection * previous salpingo and /or oophorectomy (unilateral or bilateral) * genital cancer disease or atypical endometrial hyperplasia * hyperandrogenia * any ovarian mass that needs surgical exploration * any immunotherapy that could interfere with immunological tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months) | one year |
Secondary
| Measure | Time frame |
|---|---|
| AMH measurement at 3 days, 6 weeks, and 6, 12 months after hysterectomy endovaginal ultrasound evaluation of the ovarian volume and vascularisation quality of life (WHQ questionnaire) reintervention procedures complications | day3, week 6, month 6 and month 12 |
Countries
France
Outcome results
None listed