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NCT05646680 Clinical Trial

A Performance Study of (Opportunistic) Salpingectomy

Ovarian Cancer Clinical Trial

— QOS  

Official title:
A Performance Study of (Opportunistic) Salpingectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05646680
Other study ID # BC-11611
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 9, 2022
Est. completion date January 30, 2026

Study information
Verified date December 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 30, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients scheduled for uni- or bilateral adnexectomy. (may be in combination with hysterectomy) AND * competent to act on itself - dutch speaking - signed informed consent Exclusion Criteria: * 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• two step adnexectomy
instead of standard resection of salpinx and ovary, they are now separately excised

Locations
Country Name City State
Belgium University Hospital Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of incomplete salpingectomies The rate of ovarian samples on which residual fimbrial or fallopian tube tissue has been left behind.(macroscopically and microscopically) 10 days
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