Effect of Salpingectomy During Conservative Hysterectomy (SALPINGOVA)

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

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.

Study Overview

• Status: Completed
• Conditions: Genital Diseases, Female; Uterine Prolapse; Dysfunctional Uterine Bleeding; Cervical Dysplasia; Hysterotomy; Affecting Fetus; Leiomyomata Uteri; Adenomyosis, Endometriosis
• Intervention / Treatment: Procedure: conservative hysterectomy I; Procedure: Conservative hysterectomy II

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).

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU
  • Le Kremlin-Bicêtre, France, 94 275
    • CHU
  • Lille, France, 59 037
    • CHU
  • Lyon, France, 69495
    • Hopital Sud
  • Poitiers, France, 86000
    • CHU
  • Rennes, France, 35203
    • CHU
  • Tours, France, 37044
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conservative hysterectomy I; bilateral salpingectomy during hysterectomy with conservation of the ovaries	Procedure: conservative hysterectomy I; conservative hysterectomy for benign disease
Active Comparator: conservative hysterectomy II; standard conservative hysterectomy with conservation of both ovaries and tubes	Procedure: Conservative hysterectomy II; bilateral salpingectomy during hysterectomy without conservation of the ovaries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Lobna OULDAMER, MD, Chru De Tours

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 22, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 26, 2012

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Hemorrhage; Pathological Conditions, Anatomical; Precancerous Conditions; Carcinoma in Situ; Neoplasms, Muscle Tissue; Pelvic Organ Prolapse; Cervical Intraepithelial Neoplasia; Endometriosis; Prolapse; Adenomyosis; Metrorrhagia; Leiomyoma; Uterine Cervical Dysplasia; Uterine Hemorrhage; Uterine Prolapse
• Other Study ID Numbers: PHRN11/LO/SALPINGOVA