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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 speculative1 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.

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

Conditions
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Pelvic Surgery, Routine Fallopian Tube Removal

Intervention / Treatment
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* Procedure: Routine fallopian tube removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: benign indication for hysterectomy informed consent Exclusion Criteria: Menopause Pregnancy Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...) malignancy hormone replacement therapy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery with fallopian tube removal<br>Patients receiving routine fallopian tube removal during pelvic surgery after randomization. | Procedure: Routine fallopian tube removal<br>* Fallopian tubes are removed by dissection of the Mesosalpinx.<br>|
| No Intervention: Surgery without fallopian tube removal<br>Fallopian tubes are not removed during pelvic surgery after randomization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal changes of FSH pre- and post-operatively | Follicle-stimulating hormone (U/l) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal changes of AMH | AMH (anti-mullerian hormone, U/l) | 6 weeks | 
| Longitudinal changes of LH | LH (luteinizing hormone, U/l) | 6 weeks | 
| Longitudinal changes of E2 | E2 (estradiol, U/l) | 6 weeks | 
| Longitudinal changes of FSH | Follicle-stimulating hormone (U/l) | 1 year | 
| Longitudinal changes of AMH | AMH (anti-mullerian hormone, U/l) | 1 year | 
| Longitudinal changes of LH | LH (luteinizing hormone, U/l) | 1 year | 
| Longitudinal changes of E2 | E2 (estradiol, U/l) | 1 year |