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

August 29, 2022 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Baden, Switzerland, 5404
        • Kantonsspital Baden
      • Bern, Switzerland, 3010
        • University Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • benign indication for hysterectomy
  • informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Kantonsspital Baden

Investigators

  • Study Chair: Michael D Mueller, Prof., University Women's Hospital Bern, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 057/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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