Effect of Salpingectomy During Conservative Hysterectomy (SALPINGOVA)
Primary Purpose
Genital Diseases, Female, Hysterotomy; Affecting Fetus, Leiomyomata Uteri
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
conservative hysterectomy I
Conservative hysterectomy II
Sponsored by
About this trial
This is an interventional treatment trial for Genital Diseases, Female
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
Sites / Locations
- CHU
- CHU
- CHU
- Hôpital Sud
- CHU
- CHU
- CHU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
conservative hysterectomy I
conservative hysterectomy II
Arm Description
bilateral salpingectomy during hysterectomy with conservation of the ovaries
standard conservative hysterectomy with conservation of both ovaries and tubes
Outcomes
Primary Outcome Measures
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01628432
First Posted
June 22, 2012
Last Updated
October 19, 2018
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT01628432
Brief Title
Effect of Salpingectomy During Conservative Hysterectomy
Acronym
SALPINGOVA
Official Title
Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Diseases, Female, Hysterotomy; Affecting Fetus, Leiomyomata Uteri, Adenomyosis, Endometriosis, Dysfunctional Uterine Bleeding, Cervical Dysplasia, Uterine Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conservative hysterectomy I
Arm Type
Experimental
Arm Description
bilateral salpingectomy during hysterectomy with conservation of the ovaries
Arm Title
conservative hysterectomy II
Arm Type
Active Comparator
Arm Description
standard conservative hysterectomy with conservation of both ovaries and tubes
Intervention Type
Procedure
Intervention Name(s)
conservative hysterectomy I
Intervention Description
conservative hysterectomy for benign disease
Intervention Type
Procedure
Intervention Name(s)
Conservative hysterectomy II
Intervention Description
bilateral salpingectomy during hysterectomy without conservation of the ovaries
Primary Outcome Measure Information:
Title
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
Time Frame
one year
Secondary Outcome Measure Information:
Title
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
Time Frame
day3, week 6, month 6 and month 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lobna OULDAMER, MD
Organizational Affiliation
CHRU de TOURS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHU
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94 275
Country
France
Facility Name
CHU
City
Lille
ZIP/Postal Code
59 037
Country
France
Facility Name
Hôpital Sud
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
CHU
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHU
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
CHU
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
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Effect of Salpingectomy During Conservative Hysterectomy
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