Pelvic SurgeryNCT02669498
Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal
A study testing Routine fallopian tube removal in people with Pelvic Surgery and Routine Fallopian Tube Removal, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Surgery, Routine Fallopian Tube Removal
- What is being tested?
- Routine fallopian tube removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Nov 2013to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- benign indication for hysterectomy
- informed consent
Who cannot join
- Menopause
- Pregnancy
- Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...)
- malignancy
- hormone replacement therapy
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Kantonsspital Baden
Baden, 5404
University Women's Hospital
Bern, 3010
About this study
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.
Read the 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
- Being tested
- Routine fallopian tube removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine fallopian tube removalProcedure or surgery
Fallopian tubes are removed by dissection of the Mesosalpinx.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with fallopian tube removal | Active comparator | Patients receiving routine fallopian tube removal during pelvic surgery after randomization. Receives: Procedure: Routine fallopian tube removal |
| Surgery without fallopian tube removal | No intervention | Fallopian tubes are not removed during pelvic surgery after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal changes of FSH pre- and post-operatively
Follicle-stimulating hormone (U/l)
Measured: 6 weeks
Secondary outcomes (7)
Longitudinal changes of AMH
AMH (anti-mullerian hormone, U/l)
Measured: 6 weeks
Longitudinal changes of LH
LH (luteinizing hormone, U/l)
Measured: 6 weeks
Longitudinal changes of E2
E2 (estradiol, U/l)
Measured: 6 weeks
Longitudinal changes of FSH
Follicle-stimulating hormone (U/l)
Measured: 1 year
Longitudinal changes of AMH
AMH (anti-mullerian hormone, U/l)
Measured: 1 year
Longitudinal changes of LH
LH (luteinizing hormone, U/l)
Measured: 1 year
Longitudinal changes of E2
E2 (estradiol, U/l)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startNov 2013
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baden
- Responsible party
- Sponsor
- Investigators
- Michael D Mueller, Prof., Study chair, University Women's Hospital Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669498
- Sponsor's protocol ID
- 057/12
- Status last verified
- Aug 2022
- First submitted
- 25 Jan 2016
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21849300Pokoradi 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.
PubMed 21514918
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Changing Current Standards: Endocrine Status After Routine Fallopian Tube Removal
- ClinicalTrials.gov ID
- NCT02669498
- Acronym / sponsor ID
- 057/12
- Conditions
- Pelvic Surgery, Routine Fallopian Tube Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Kantonsspital Baden
- Study start
- Nov 2013
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery with fallopian tube removal | Active comparator | Procedure: Routine fallopian tube removalPatients receiving routine fallopian tube removal during pelvic surgery after randomization. |
| Surgery without fallopian tube removal | No intervention | –Fallopian tubes are not removed during pelvic surgery after randomization. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- benign indication for hysterectomy
- informed consent
Key exclusion criteria (5 listed)
- Menopause
- Pregnancy
- Previous pelvic surgery (hysterectomy, salpingectomy, tubal ligation,...)
- malignancy
- hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine fallopian tube removalFallopian tubes are removed by dissection of the Mesosalpinx. | Procedure or surgery | Surgery with fallopian tube removal |
Primary outcome
Longitudinal changes of FSH pre- and post-operatively
Time frame: 6 weeks
Follicle-stimulating hormone (U/l)
7 secondary outcomes
Longitudinal changes of AMH
Time frame: 6 weeks
Longitudinal changes of LH
Time frame: 6 weeks
Longitudinal changes of E2
Time frame: 6 weeks
Longitudinal changes of FSH
Time frame: 1 year
Longitudinal changes of AMH
Time frame: 1 year
Longitudinal changes of LH
Time frame: 1 year
Longitudinal changes of E2
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Results publication: PubMed 21849300Dietl 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.
- Results publication: PubMed 21514918Pokoradi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Mueller, Prof. study chair
University Women's Hospital Bern, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine fallopian tube removal in people with Pelvic Surgery and Routine Fallopian Tube Removal, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal changes of FSH pre- and post-operatively (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02669498, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.