Clinical Trials Directory

Trials / Completed

CompletedNCT06825468

Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors

Role Of Hysterectomy In The Treatment Of Borderline Ovarian Tumors

Status
Completed
Phase
Study type
Observational
Enrollment
168 (actual)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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

Timeline

Start date
2022-01-10
Primary completion
2024-12-31
Completion
2025-01-31
First posted
2025-02-13
Last updated
2025-02-13

Locations

3 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT06825468. Inclusion in this directory is not an endorsement.