Effect of Salpingectomy During Conservative Hysterectomy

Cervical Dysplasia Clinical Trial

— SALPINGOVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628432
• Other study ID #: PHRN11/LO/SALPINGOVA
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Adenomyosis, Endometriosis
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Dysfunctional Uterine Bleeding
• Endometriosis
• Genital Diseases, Female
• Hysterotomy; Affecting Fetus
• Leiomyoma
• Leiomyomata Uteri
• Metrorrhagia
• Prolapse
• Uterine Cervical Dysplasia
• Uterine Hemorrhage
• Uterine Prolapse

Intervention

Procedure:
• conservative hysterectomy I
conservative hysterectomy for benign disease
• Conservative hysterectomy II
bilateral salpingectomy during hysterectomy without conservation of the ovaries

Locations

Country	Name	City	State
France	CHU	Angers
France	CHU	Le Kremlin-Bicêtre
France	CHU	Lille
France	Hôpital Sud	Lyon
France	CHU	Poitiers
France	CHU	Rennes
France	CHU	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)		one year
Secondary	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