Clinical trial NCT02669498: Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal
Official title: Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Surgery
Routine Fallopian Tube Removal
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Kantonsspital Baden
First posted: 2016-02-01
Enrollment: 128
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* benign indication for hysterectomy
* informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Longitudinal changes of FSH pre- and post-operatively
timeFrame: 6 weeks
Secondary outcomes:
measure: Longitudinal changes of AMH
timeFrame: 6 weeks
measure: Longitudinal changes of LH
timeFrame: 6 weeks
measure: Longitudinal changes of E2
timeFrame: 6 weeks
measure: Longitudinal changes of FSH
timeFrame: 1 year
measure: Longitudinal changes of AMH
timeFrame: 1 year
measure: Longitudinal changes of LH
timeFrame: 1 year
measure: Longitudinal changes of E2
timeFrame: 1 year
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Bern
country: Switzerland
facility: University Women's Hospital
Study officials:
affiliation: University Women's Hospital Bern, Switzerland
name: Michael D Mueller, Prof.
role: STUDY_CHAIR
References:
citation: 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.
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.