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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02669498
Enrollment
128
Registered
2016-02-01
Start date
2013-11-30
Completion date
2021-12-01
Last updated
2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Surgery, Routine Fallopian Tube Removal

Brief summary

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

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.

Interventions

PROCEDURERoutine fallopian tube removal

Fallopian tubes are removed by dissection of the Mesosalpinx.

Sponsors

Kantonsspital Baden
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* benign indication for hysterectomy * informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal changes of FSH pre- and post-operatively6 weeksFollicle-stimulating hormone (U/l)

Secondary

MeasureTime frameDescription
Longitudinal changes of AMH6 weeksAMH (anti-mullerian hormone, U/l)
Longitudinal changes of LH6 weeksLH (luteinizing hormone, U/l)
Longitudinal changes of E26 weeksE2 (estradiol, U/l)
Longitudinal changes of FSH1 yearFollicle-stimulating hormone (U/l)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026