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Completed

NCT Number: NCT01628432

Effect of Salpingectomy During Conservative 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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conservative hysterectomy I

Procedure

conservative hysterectomy for benign disease

Conservative hysterectomy II

Procedure

bilateral salpingectomy during hysterectomy without conservation of the ovaries

Primary outcomes

  1. percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)

    Time frame: 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

    Time frame: day3, week 6, month 6 and month 12

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial

Acronym: SALPINGOVA

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jun 26, 2012
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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