Clinical trial NCT06825468: Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors
Official title: Role Of Hysterectomy In The Treatment Of Borderline Ovarian Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Keywords: Borderline ovarian tumours
gynaecology
perimenopause
postmenopause
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 168
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with BOT diagnosis will be included in the study for analysis:

* BSO and hysterectomy (group 1)
* BSO without hysterectomy (group 2)

Brief summary: Borderline ovarian tumors (BOT), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion.

Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral adnexectomy. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.

Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.

Detailed description: Borderline ovarian tumors (BOTs), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. Serous BOTs, which account for 67% of all BOTs, are limited to one ovary in 75% of cases and are frequently accompanied by predominantly noninvasive peritoneal implants. In 30% of cases, BOTs are mucinous, unilateral, and characterized by a low rate of extra-ovarian spread and invasive implants. Patients with BOT are diagnosed at FIGO stage I in 78.9% of cases, are usually young, and have a favorable prognosis with 5-year survival affecting more than 80% of patients.

Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral annissiectomy. Otherwise, the role of hysterectomy in perimenopausal and postmenopausal women with early-stage BOT remains unclear. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.

Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* Women in menopause clinically defined as absence of menstrual cycle for 12 months
* Primary diagnosis of BOT confirmed by pathological examination
* Surgical treatment of BOT by BSO with (group 1) and without (group 2) hysterectomy
* Informed consent acquisition

Exclusion Criteria:

* Occurrence of BOT at index intervention
* Stage IV
* Metastatic disease
* Patients with previous hysterectomy
* Cancer synchronous of the endometrium
* Patients who have not had follow-up before 5 years (excluding those who have not reached the 5 year follow-up for the following events: death from any cause, death from BOT, recurrence of BOT)

Primary outcomes:
measure: Impact of uterine preservation on the rate of BOT recurrence
timeFrame: After surgery during follow up (up to 20 years)
Secondary outcomes:
measure: The rate of recurrence of BOT and of invasive implants
timeFrame: After surgery during follow up (up to 20 years)
measure: The rate of carcinoma recurrence
timeFrame: After surgery during follow up (up to 20 years)
measure: the overall survival (OS) defined as the time from surgery to the patient's death from any cause
timeFrame: After surgery during follow up (up to 20 years)
measure: disease-free survival (DFS) defined as time from surgery to recurrence
timeFrame: After surgery during follow up
measure: disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease
timeFrame: After surgery during follow up (up to 20 years)
measure: the rate of postoperative complications
timeFrame: After surgery during follow up (up to 20 years)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli, IRCCS
city: Udine
country: Italy
facility: Ospedale universitario, Azienda Sanitaria Universitaria Friuli Centrale
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Diego Raimondo, MD
role: PRINCIPAL_INVESTIGATOR
References: