Genital Diseases, FemaleSALPINGOVANCT01628432
Effect of Salpingectomy During Conservative Hysterectomy
A study testing conservative hysterectomy I and Conservative hysterectomy II in people with Genital Diseases, Female and Hysterotomy; Affecting Fetus, run by University Hospital, Tours at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Genital Diseases, Female, Hysterotomy; Affecting Fetus, Leiomyomata Uteri
- What is being tested?
- conservative hysterectomy I and Conservative hysterectomy II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 7 sitesFrance
- Study dates
- Jul 2012to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- genital cancer disease or atypical endometrial hyperplasia
- hyperandrogenia
- any ovarian mass that needs surgical exploration
- any immunotherapy that could interfere with immunological tests
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU
Angers, 49933
CHU
Le Kremlin-Bicêtre, 94 275
CHU
Lille, 59 037
Hôpital Sud
Lyon, 69495
CHU
Poitiers, 86000
CHU
Rennes, 35203
CHU
Tours, 37044
About this study
Official title: 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.
Read the 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
- Being tested
- conservative hysterectomy I, Conservative hysterectomy II
- Medical subject headings
- Genital Diseases, Female, Adenomyosis, Endometriosis, Metrorrhagia, Uterine Cervical Dysplasia, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative hysterectomy IProcedure or surgery
conservative hysterectomy for benign disease
Conservative hysterectomy IIProcedure or surgery
bilateral salpingectomy during hysterectomy without conservation of the ovaries
| Study group | Role | What they receive |
|---|---|---|
| conservative hysterectomy I | Experimental | bilateral salpingectomy during hysterectomy with conservation of the ovaries Receives: Procedure: conservative hysterectomy I |
| conservative hysterectomy II | Active comparator | standard conservative hysterectomy with conservation of both ovaries and tubes Receives: Procedure: Conservative hysterectomy II |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
Measured: 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
Measured: day3, week 6, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Diseases, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lobna OULDAMER, MD, Principal investigator, CHRU de TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628432
- Sponsor's protocol ID
- PHRN11/LO/SALPINGOVA
- Acronym
- SALPINGOVA
- Status last verified
- Oct 2018
- First submitted
- 22 Jun 2012
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01628432
- Acronym / sponsor ID
- SALPINGOVA / PHRN11/LO/SALPINGOVA
- Conditions
- Genital Diseases, Female, Hysterotomy; Affecting Fetus, Leiomyomata Uteri, Adenomyosis, Endometriosis, Dysfunctional Uterine Bleeding, Cervical Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative hysterectomy I | Experimental | Procedure: conservative hysterectomy Ibilateral salpingectomy during hysterectomy with conservation of the ovaries |
| conservative hysterectomy II | Active comparator | Procedure: Conservative hysterectomy IIstandard conservative hysterectomy with conservation of both ovaries and tubes |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conservative hysterectomy Iconservative hysterectomy for benign disease | Procedure or surgery | conservative hysterectomy I |
| Conservative hysterectomy IIbilateral salpingectomy during hysterectomy without conservation of the ovaries | Procedure or surgery | conservative hysterectomy II |
Primary outcome
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)
Time frame: one year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lobna OULDAMER, MD principal investigator
CHRU de TOURS
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative hysterectomy I and Conservative hysterectomy II in people with Genital Diseases, Female and Hysterotomy; Affecting Fetus, run by University Hospital, Tours at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.