Clinical trial NCT01628432: Effect of Salpingectomy During Conservative Hysterectomy
Official title: Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Diseases, Female
Hysterotomy; Affecting Fetus
Leiomyomata Uteri
Adenomyosis, Endometriosis
Dysfunctional Uterine Bleeding
Cervical Dysplasia
Uterine Prolapse
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
timeFrame: one year
Secondary outcomes:
measure: 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
timeFrame: day3, week 6, month 6 and month 12
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
city: Le Kremlin-Bicêtre
country: France
facility: CHU
city: Lille
country: France
facility: CHU
city: Lyon
country: France
facility: Hôpital Sud
city: Poitiers
country: France
facility: CHU
city: Rennes
country: France
facility: CHU
city: Tours
country: France
facility: CHU
Study officials:
affiliation: CHRU de TOURS
name: Lobna OULDAMER, MD
role: PRINCIPAL_INVESTIGATOR
References: