Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors

Completed

• Conditions: Hysterectomy

• Registration Number: NCT06825468
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2022-01-10
• Status Verified: 2024-11
• Study First Submitted: 2024-12-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of uterine preservation on the rate of BOT recurrence	After surgery during follow up (up to 20 years)	Impact of uterine preservation on the rate of borderline ovarian tumors (BOT) recurrence and thus its usefulness or otherwise in clinical care practice; therefore, the overall recurrence rate (which includes BOT, invasive BOT implants, and carcinoma) in patients treated with (group 1) and without (group 2) hysterectomy will be determined

Secondary Outcome Measures

Name	Time	Method
The rate of recurrence of BOT and of invasive implants	After surgery during follow up (up to 20 years)	Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of recurrence of BOT and of invasive implants
The rate of carcinoma recurrence	After surgery during follow up (up to 20 years)	Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of carcinoma recurrence
the overall survival (OS) defined as the time from surgery to the patient's death from any cause	After surgery during follow up (up to 20 years)	Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the overall survival (OS) defined as the time from surgery to the patient's death from any cause
disease-free survival (DFS) defined as time from surgery to recurrence	After surgery during follow up	Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy disease-free survival (DFS) defined as time from surgery to recurrence
disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease	After surgery during follow up (up to 20 years)	Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease
the rate of postoperative complications	After surgery during follow up (up to 20 years)	Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of postoperative complications

Trial Locations

Locations (3)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

Fondazione Policlinico Universitario A. Gemelli, IRCCS; 🇮🇹 Roma, Italy

Ospedale universitario, Azienda Sanitaria Universitaria Friuli Centrale; 🇮🇹 Udine, Italy