NCT01628432

Effect of Salpingectomy During Conservative Hysterectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: Female
• Age: 18 Years – 52 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	conservative hysterectomy I	conservative hysterectomy for benign disease
PROCEDURE	Conservative hysterectomy II	bilateral salpingectomy during hysterectomy without conservation of the ovaries

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-05-01
• Completion: 2018-06-01
• First posted: 2012-06-26
• Last updated: 2018-10-22

Locations

7 sites across 1 country: France