Effect of Salpingectomy During Conservative Hysterectomy (SALPINGOVA)

Regional University Hospital Center (CHRU)

Status: Completed

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

Treatments: Procedure: Conservative hysterectomy II; Procedure: conservative hysterectomy I

Study type: Interventional

Funder types: Other

Identifiers

NCT01628432

PHRN11/LO/SALPINGOVA

Details and patient eligibility

About

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.

Full 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).

Enrollment: 350 patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

conservative hysterectomy I

Experimental group

Description:

bilateral salpingectomy during hysterectomy with conservation of the ovaries

Treatment:

Procedure: conservative hysterectomy I

conservative hysterectomy II

Active Comparator group

Description:

standard conservative hysterectomy with conservation of both ovaries and tubes

Treatment:

Procedure: Conservative hysterectomy II