Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors

NCT ID: NCT06825468

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2025-01-31

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.

Conditions

Hysterectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diego Raimondo, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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

Countries

Italy

Other Identifiers

HYSTEROBOT

Identifier Type: -

Identifier Source: org_study_id