Effect of Salpingectomy During Conservative Hysterectomy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial

Conditions
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Genital Diseases, Female, Hysterotomy; Affecting Fetus, Leiomyomata Uteri, Adenomyosis, Endometriosis, Dysfunctional Uterine Bleeding, Cervical Dysplasia, Uterine Prolapse

Intervention / Treatment
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* Procedure: conservative hysterectomy I
* Procedure: Conservative hysterectomy II


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conservative hysterectomy I<br>bilateral salpingectomy during hysterectomy with conservation of the ovaries | Procedure: conservative hysterectomy I<br>* conservative hysterectomy for benign disease<br>|
| Active Comparator: conservative hysterectomy II<br>standard conservative hysterectomy with conservation of both ovaries and tubes | Procedure: Conservative hysterectomy II<br>* bilateral salpingectomy during hysterectomy without conservation of the ovaries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |