Effect of Salpingectomy During Conservative Hysterectomy (SALPINGOVA)
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|ClinicalTrials.gov Identifier: NCT01628432|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2012
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Genital Diseases, Female Hysterotomy; Affecting Fetus Leiomyomata Uteri Adenomyosis, Endometriosis Dysfunctional Uterine Bleeding Cervical Dysplasia Uterine Prolapse||Procedure: conservative hysterectomy I Procedure: Conservative hysterectomy II||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||October 2018|
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
- percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months) [ Time Frame: one year ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628432
|Angers, France, 49933|
|Le Kremlin-Bicêtre, France, 94 275|
|Lille, France, 59 037|
|Lyon, France, 69495|
|Poitiers, France, 86000|
|Rennes, France, 35203|
|Tours, France, 37044|
|Principal Investigator:||Lobna OULDAMER, MD||CHRU de TOURS|