Trials Sponsors Conditions Drugs Pricing

Conditions

Hysterectomy

Keywords

Borderline ovarian tumoursgynaecologyperimenopausepostmenopause

Outcome Measures

Primary Outcomes (1)

Impact of uterine preservation on the rate of BOT recurrence
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
After surgery during follow up (up to 20 years)

Secondary Outcomes (6)

The rate of recurrence of BOT and of invasive implants
After surgery during follow up (up to 20 years)
The rate of carcinoma recurrence
After surgery during follow up (up to 20 years)
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)
disease-free survival (DFS) defined as time from surgery to recurrence
After surgery during follow up
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)
+1 more secondary outcomes

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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)

You may qualify if:

Women in menopause clinically defined as absence of menstrual cycle for 12 months

Sponsors & Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Otherlead

Study Sites (3)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Roma, 00136, Italy

Ospedale universitario, Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy

Study Officials

Diego Raimondo, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
PRINCIPAL INVESTIGATOR

Enrollment

168 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 30, 2024

First Posted

February 13, 2025

Study Start

January 10, 2022

Actual (reported)

Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations