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.

Study Overview

• Status: Completed
• Conditions: Pelvic Surgery; Routine Fallopian Tube Removal
• Intervention / Treatment: Procedure: Routine fallopian tube removal

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• 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

General Publications

• Dietl J, Wischhusen J, Hausler SF. The post-reproductive Fallopian tube: better removed? Hum Reprod. 2011 Nov;26(11):2918-24. doi: 10.1093/humrep/der274. Epub 2011 Aug 16.
• Pokoradi AJ, Iversen L, Hannaford PC. Factors associated with age of onset and type of menopause in a cohort of UK women. Am J Obstet Gynecol. 2011 Jul;205(1):34.e1-13. doi: 10.1016/j.ajog.2011.02.059. Epub 2011 Feb 27.

Study record dates

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