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

Not Applicable

Completed

• Conditions: Pelvic Surgery; Routine Fallopian Tube Removal
• Interventions: Procedure: Routine fallopian tube removal

• Registration Number: NCT02669498
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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 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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• benign indication for hysterectomy
• informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery with fallopian tube removal	Routine fallopian tube removal	Patients receiving routine fallopian tube removal during pelvic surgery after randomization.

Primary Outcome Measures

Name	Time	Method
Longitudinal changes of FSH pre- and post-operatively	6 weeks	Follicle-stimulating hormone (U/l)

Secondary Outcome Measures

Name	Time	Method
Longitudinal changes of AMH	1 year	AMH (anti-mullerian hormone, U/l)
Longitudinal changes of LH	1 year	LH (luteinizing hormone, U/l)
Longitudinal changes of E2	1 year	E2 (estradiol, U/l)
Longitudinal changes of FSH	1 year	Follicle-stimulating hormone (U/l)

Trial Locations

Locations (2)

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

University Women's Hospital; 🇨🇭 Bern, Switzerland