Effect of Salpingectomy During Conservative Hysterectomy
- Conditions
- Uterine ProlapseHysterotomy; Affecting FetusLeiomyomata UteriCervical DysplasiaGenital Diseases, FemaleAdenomyosis, EndometriosisDysfunctional Uterine Bleeding
- Interventions
- Procedure: conservative hysterectomy IProcedure: Conservative hysterectomy II
- Registration Number
- NCT01628432
- Lead Sponsor
- University Hospital, Tours
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 350
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conservative hysterectomy I conservative hysterectomy I bilateral salpingectomy during hysterectomy with conservation of the ovaries conservative hysterectomy II Conservative hysterectomy II standard conservative hysterectomy with conservation of both ovaries and tubes
- Primary Outcome Measures
Name Time Method percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months) one year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
CHU
🇫🇷Tours, France
Hôpital Sud
🇫🇷Lyon, France