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

Pelvic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669498
• Other study ID #: 057/12
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• benign indication for hysterectomy

• informed consent

Exclusion Criteria:

• Menopause

• Pregnancy

• Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...)

• malignancy

• hormone replacement therapy

Related Conditions & MeSH terms

• Pelvic Surgery
• Routine Fallopian Tube Removal

Intervention

Procedure:
• Routine fallopian tube removal
Fallopian tubes are removed by dissection of the Mesosalpinx.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden
Switzerland	University Women's Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Kantonsspital Baden

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Dietl J, Wischhusen J, Häusler 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal changes of FSH pre- and post-operatively	Follicle-stimulating hormone (U/l)	6 weeks
Secondary	Longitudinal changes of AMH	AMH (anti-mullerian hormone, U/l)	6 weeks
Secondary	Longitudinal changes of LH	LH (luteinizing hormone, U/l)	6 weeks
Secondary	Longitudinal changes of E2	E2 (estradiol, U/l)	6 weeks
Secondary	Longitudinal changes of FSH	Follicle-stimulating hormone (U/l)	1 year
Secondary	Longitudinal changes of AMH	AMH (anti-mullerian hormone, U/l)	1 year
Secondary	Longitudinal changes of LH	LH (luteinizing hormone, U/l)	1 year
Secondary	Longitudinal changes of E2	E2 (estradiol, U/l)	1 year