Adnexal LesionQOSNCT05646680
A Performance Study of (Opportunistic) Salpingectomy
A study testing two step adnexectomy in people with Adnexal Lesion and Ovarian Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to test the quality of the performance of opportunistic salpingectomies in women scheduled for adnexectomy. The main questions it aims to answer are: How many salpingectomies are incomplete? Are there any factors related to incomplete resection? Could the investigators develop a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Lesion, Ovarian Cancer
- What is being tested?
- two step adnexectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Dec 2022to 25 Apr 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for uni- or bilateral adnexectomy. (may be in combination with hysterectomy) AND competent to act on itself
- dutch speaking
- signed informed consent
Who cannot join
- Endometrial cancer or invasive cervical cancer
- radiotherapy in the pelvis in the medical history
- (partial) salpingectomy
- Pelvic Inflammatory Disease
- Adnexectomy for gender transformation surgery if wish to preserve the ovarian tissue.
- Surgery in two steps is not safe to perform
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test the quality of the performance of opportunistic salpingectomies in women scheduled for adnexectomy. The main questions it aims to answer are:
- How many salpingectomies are incomplete?
- Are there any factors related to incomplete resection? Could the investigators develop a instruction video to optimize the surgical technique?
Participants planned for uni-or bilateral adnexectomy (removal of ovary and salpinx) will have their adnexectomy in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary).
Read the detailed description
Rationale: Salpingectomy in post-reproductive women could reduce the risk of developing ovarian cancer. In women at high risk for ovarian cancer (because of genetic mutations) a risk reducing salpingectomy with delayed ovariectomy could be an advantage. It is considered that salpingectomy does not cause premature menopausal symptoms. Prospective randomized trials are being performed to estimate the true risk reducing effect of salpingectomy on ovarian cancer. Those studies are based on a complete bilateral salpingectomy.
Objective: The QOS study investigates the quality of performance of opportunistic salpingectomy and the risk factors associated with reminiscing fimbrial tissue after salpingectomy.
Study design: Multicenter interventional trial
Study population: Patients planned for unilateral or bilateral adnexectomy (removal of ovary and salpinx) will be counselled to participate.
Intervention: The gynecologist will perform the adnexectomy in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary). The pathologist investigates for pathology and describes if fimbrial tissue (the last part of the salpinx adjacent to the ovary) has been left behind on the ovarian surface microscopically and macroscopically.
Main study parameters/endpoints: The primary outcome is the percentage of incomplete salpingectomies. Secondary outcome is the detection of factors related to incomplete resection of the salpinx. If necessary a guideline/instruction video could be developed to optimize the surgical technique. A total of 200 specimens are to be included to answer the primary endpoint.
- Conditions
- Adnexal Lesion, Ovarian Cancer
- Being tested
- two step adnexectomy
- Keywords
- salpingectomy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two step adnexectomyProcedure or surgery
instead of standard resection of salpinx and ovary, they are now separately excised
| Study group | Role | What they receive |
|---|---|---|
| two step adnexectomy | Other | Patients planned for unilateral or bilateral adnexectomy (removal of ovary and salpinx) will have their adnexectomy performed in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary). Receives: Procedure: two step adnexectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of incomplete salpingectomies
The rate of ovarian samples on which residual fimbrial or fallopian tube tissue has been left behind.(macroscopically and microscopically)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start9 Dec 2022
- Primary completion12 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal LesionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646680
- Sponsor's protocol ID
- BC-11611
- Acronym
- QOS
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2022
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Performance Study of (Opportunistic) Salpingectomy
- ClinicalTrials.gov ID
- NCT05646680
- Acronym / sponsor ID
- QOS / BC-11611
- Conditions
- Adnexal Lesion, Ovarian Cancer
- Keywords
- salpingectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 12 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 12 Dec 2022 (actual)
- 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.
The goal of this clinical trial is to test the quality of the performance of opportunistic salpingectomies in women scheduled for adnexectomy. The main questions it aims to answer are:
- How many salpingectomies are incomplete?
- Are there any factors related to incomplete resection? Could the investigators develop a instruction video to optimize the surgical technique?
Participants planned for uni-or bilateral adnexectomy (removal of ovary and salpinx) will have their adnexectomy in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary).
Detailed description
Rationale: Salpingectomy in post-reproductive women could reduce the risk of developing ovarian cancer. In women at high risk for ovarian cancer (because of genetic mutations) a risk reducing salpingectomy with delayed ovariectomy could be an advantage. It is considered that salpingectomy does not cause premature menopausal symptoms. Prospective randomized trials are being performed to estimate the true risk reducing effect of salpingectomy on ovarian cancer. Those studies are based on a complete bilateral salpingectomy.
Objective: The QOS study investigates the quality of performance of opportunistic salpingectomy and the risk factors associated with reminiscing fimbrial tissue after salpingectomy.
Study design: Multicenter interventional trial
Study population: Patients planned for unilateral or bilateral adnexectomy (removal of ovary and salpinx) will be counselled to participate.
Intervention: The gynecologist will perform the adnexectomy in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary). The pathologist investigates for pathology and describes if fimbrial tissue (the last part of the salpinx adjacent to the ovary) has been left behind on the ovarian surface microscopically and macroscopically.
Main study parameters/endpoints: The primary outcome is the percentage of incomplete salpingectomies. Secondary outcome is the detection of factors related to incomplete resection of the salpinx. If necessary a guideline/instruction video could be developed to optimize the surgical technique. A total of 200 specimens are to be included to answer the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two step adnexectomy | Other | Procedure: two step adnexectomyPatients planned for unilateral or bilateral adnexectomy (removal of ovary and salpinx) will have their adnexectomy performed in two steps in the same surgical episode: first the salpingectomy (removal of the salpinx), then the oophorectomy (the removal of the ovary). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for uni- or bilateral adnexectomy. (may be in combination with hysterectomy) AND competent to act on itself
- dutch speaking
- signed informed consent
Key exclusion criteria (7 listed)
- Endometrial cancer or invasive cervical cancer
- radiotherapy in the pelvis in the medical history
- (partial) salpingectomy
- Pelvic Inflammatory Disease
- Adnexectomy for gender transformation surgery if wish to preserve the ovarian tissue.
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 |
|---|---|---|
| two step adnexectomyinstead of standard resection of salpinx and ovary, they are now separately excised | Procedure or surgery | two step adnexectomy |
Primary outcome
Percentage of incomplete salpingectomies
Time frame: 10 days
The rate of ovarian samples on which residual fimbrial or fallopian tube tissue has been left behind.(macroscopically and microscopically)
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 29 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two step adnexectomy in people with Adnexal Lesion and Ovarian Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 7 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Percentage of incomplete salpingectomies (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.