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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Routine Fallopian Tube Removal; Pelvic Surgery

Treatments: Procedure: Routine fallopian tube removal

Study type: Interventional

Funder types: Other

Identifiers

NCT02669498

057/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• benign indication for hysterectomy
• informed consent

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Surgery with fallopian tube removal

Active Comparator group

Description:

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

Treatment:

Procedure: Routine fallopian tube removal

Surgery without fallopian tube removal

No Intervention group

Description:

Fallopian tubes are not removed during pelvic surgery after randomization.