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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

June 22, 2012
June 26, 2012
November 24, 2017
July 2012
August 2017   (Final data collection date for primary outcome measure)
percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months) [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01628432 on ClinicalTrials.gov Archive Site
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 ]
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) retintervention procedures complications [ Time Frame: day3, week 6, month 6 and month 12 ]
Not Provided
Not Provided
 
Effect of Salpingectomy During Conservative Hysterectomy
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.

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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Genital Diseases, Female
  • Hysterotomy; Affecting Fetus
  • Leiomyomata Uteri
  • Adenomyosis, Endometriosis
  • Dysfunctional Uterine Bleeding
  • Cervical Dysplasia
  • Uterine Prolapse
  • Procedure: conservative hysterectomy I
    conservative hysterectomy for benign disease
  • Procedure: Conservative hysterectomy II
    bilateral salpingectomy during hysterectomy without conservation of the ovaries
  • Experimental: conservative hysterectomy I
    bilateral salpingectomy during hysterectomy with conservation of the ovaries
    Intervention: Procedure: conservative hysterectomy I
  • Active Comparator: conservative hysterectomy II
    standard conservative hysterectomy with conservation of both ovaries and tubes
    Intervention: Procedure: Conservative hysterectomy II
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
350
Same as current
October 2018
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 52 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01628432
PHRN11/LO/SALPINGOVA
No
Not Provided
Not Provided
University Hospital, Tours
University Hospital, Tours
Not Provided
Principal Investigator: Lobna OULDAMER, MD CHRU de TOURS
University Hospital, Tours
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP