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

NCT ID: NCT02669498

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2021-12-01

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.

Conditions

Pelvic Surgery; Routine Fallopian Tube Removal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Surgery with fallopian tube removal

Patients receiving routine fallopian tube removal during pelvic surgery after randomization.

Group Type: ACTIVE_COMPARATOR

Routine fallopian tube removal

Intervention Type: PROCEDURE

Fallopian tubes are removed by dissection of the Mesosalpinx.

Surgery without fallopian tube removal

Fallopian tubes are not removed during pelvic surgery after randomization.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Routine fallopian tube removal

Fallopian tubes are removed by dissection of the Mesosalpinx.

Intervention Type: PROCEDURE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kantonsspital Baden

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael D Mueller, Prof.

Role: STUDY_CHAIR

University Women's Hospital Bern, Switzerland

Locations

Kantonsspital Baden

Baden, , Switzerland

University Women's Hospital

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 21849300 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21514918 (View on PubMed)

Other Identifiers

057/12

Identifier Type: -

Identifier Source: org_study_id