A Performance Study of (Opportunistic) Salpingectomy (QOS)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Ovarian Cancer; Adnexal Lesion

Treatments: Procedure: two step adnexectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05646680

BC-11611

Details and patient eligibility

About

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).

Full 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.

Enrollment: 115 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

two step adnexectomy

Other group

Description:

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).

Treatment:

Procedure: two step adnexectomy