Effect of Salpingectomy During Conservative Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-06-30

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.

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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conservative hysterectomy I

bilateral salpingectomy during hysterectomy with conservation of the ovaries

Group Type EXPERIMENTAL

conservative hysterectomy I

Intervention Type PROCEDURE

conservative hysterectomy for benign disease

conservative hysterectomy II

standard conservative hysterectomy with conservation of both ovaries and tubes

Group Type ACTIVE_COMPARATOR

Conservative hysterectomy II

Intervention Type PROCEDURE

bilateral salpingectomy during hysterectomy without conservation of the ovaries

Interventions

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conservative hysterectomy I

conservative hysterectomy for benign disease

Intervention Type PROCEDURE

Conservative hysterectomy II

bilateral salpingectomy during hysterectomy without conservation of the ovaries

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No