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
1 other identifier
interventional
350
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 26, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 22, 2018
October 1, 2018
4.8 years
June 22, 2012
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
one year
Secondary Outcomes (1)
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
Study Arms (2)
conservative hysterectomy I
EXPERIMENTALbilateral salpingectomy during hysterectomy with conservation of the ovaries
conservative hysterectomy II
ACTIVE COMPARATORstandard conservative hysterectomy with conservation of both ovaries and tubes
Interventions
conservative hysterectomy for benign disease
bilateral salpingectomy during hysterectomy without conservation of the ovaries
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CHU
Angers, 49933, France
CHU
Le Kremlin-Bicêtre, 94 275, France
CHU
Lille, 59 037, France
Hôpital Sud
Lyon, 69495, France
CHU
Poitiers, 86000, France
CHU
Rennes, 35203, France
CHU
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lobna OULDAMER, MD
CHRU de TOURS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2012
First Posted
June 26, 2012
Study Start
July 1, 2012
Primary Completion
May 1, 2017
Study Completion
June 1, 2018
Last Updated
October 22, 2018
Record last verified: 2018-10