Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-12-09
2026-01-30
Brief Summary
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* 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).
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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two step adnexectomy
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).
two step adnexectomy
instead of standard resection of salpinx and ovary, they are now separately excised
Interventions
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two step adnexectomy
instead of standard resection of salpinx and ovary, they are now separately excised
Eligibility Criteria
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Inclusion Criteria
* dutch speaking
* signed informed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Locations
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University Hospital
Ghent, , Belgium
Countries
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Facility Contacts
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Other Identifiers
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BC-11611
Identifier Type: -
Identifier Source: org_study_id
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