A Performance Study of (Opportunistic) Salpingectomy

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).

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Key information

Conditions

Adnexal Lesion Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

two step adnexectomy

Procedure

instead of standard resection of salpinx and ovary, they are now separately excised

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: QOS

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Dec 12, 2022
Registry last updated: Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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