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Completed

NCT Number: NCT02669498

Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal

Two recently published articles need to be cited to explain the rationale for our study since both studies conclude with contrary findings: The first one is "The post-reproductive Fallopian tube: better removed?" and the other is termed "Factors associated with age of onset and type of menopause in a cohort of UK women".

In essence, while Dietl et al suggest to remove the Fallopian tube routinely in every hysterectomy and every sterilization procedure after 35 yrs of age, Pokoradi et al showed that pelvic surgical procedures and even simple tubal sterilization are associated with an earlier menopause. Hence, this is an important issue as early menopause leads to adverse health status.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Baden, Baden, Switzerland

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About this study

Two study findings lead to conflictive points of view. On the one hand a routine removal of the Fallopian tubes is proclaimed to reduce cancer risk, on the other hand we know that surgical pelvic procedures result in early onset of menopause. Pokoradi et al were not able to distinctively tell which part of pelvic surgery (ie hysterectomy, oophorectomy, salpingectomy, tubal ligation?) is affecting menopause because data was not providing surgical details. Nevertheless, Dietl et al's statement "Timing of menopause and other long-term effects have not been studied yet...thus all negative effects are still speculative"1 can only partly be agreed upon regarding Pokoradi's findings. It might be too early to proclaim a routine Fallopian tube removal as long as there is no data on how much this procedure affects ovarian function. This is further supported by another statement in their study "Although most malignant serous "ovarian" carcinomas originate from the distal Fallopian tube, a smaller proportion of serous cancers as well as endometroid, clear cell, mucinous carcinomas are still thought to arise from ovarian surface epithelium.1" which means the exact impact on cancer prophylaxis can only be estimated due to a lack of studies. Other histopathologic entities might not be influenced by tube removal.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • benign indication for hysterectomy
  • informed consent

Exclusion criteria

  • Menopause
  • Pregnancy
  • Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...)
  • malignancy
  • hormone replacement therapy

Treatment and study plan

Routine fallopian tube removal

Procedure

Fallopian tubes are removed by dissection of the Mesosalpinx.

Primary outcomes

  1. Longitudinal changes of FSH pre- and post-operatively

    Time frame: 6 weeks

    Follicle-stimulating hormone (U/l)

Secondary outcomes

  1. Longitudinal changes of AMH

    Time frame: 6 weeks

    AMH (anti-mullerian hormone, U/l)

  2. Longitudinal changes of LH

    Time frame: 6 weeks

    LH (luteinizing hormone, U/l)

  3. Longitudinal changes of E2

    Time frame: 6 weeks

    E2 (estradiol, U/l)

  4. Longitudinal changes of FSH

    Time frame: 1 year

    Follicle-stimulating hormone (U/l)

  5. Longitudinal changes of AMH

    Time frame: 1 year

    AMH (anti-mullerian hormone, U/l)

  6. Longitudinal changes of LH

    Time frame: 1 year

    LH (luteinizing hormone, U/l)

  7. Longitudinal changes of E2

    Time frame: 1 year

    E2 (estradiol, U/l)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Kantonsspital Baden

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2016
Registry last updated
Sep 1, 2022

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

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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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