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Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Completed

Conditions

Hysterectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06825468
HYSTEROBOT

Details and patient eligibility

About

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.

Full 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.

Enrollment

168 patients

Sex

Female

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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