A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-08

Study Completion Date

2028-03-08

Brief Summary

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The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic.

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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Participants scheduled for non-gynecologic abdominopelvic surgery

Participants will be aged ≥45 years, have at least 1 fallopian tube, will not desire or plan to have children in the future, and will be scheduled to undergo non-gynecologic abdominopelvic surgery.

Group Type EXPERIMENTAL

Educational Module

Intervention Type BEHAVIORAL

Part 1 consists of an education module with premodule and postmodule assessment questionnaires.

Salpingectomy

Intervention Type PROCEDURE

Part 2 consists of incorporating opportunistic salpingectomy /OS into non-gynecologic surgery

Interventions

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Educational Module

Part 1 consists of an education module with premodule and postmodule assessment questionnaires.

Intervention Type BEHAVIORAL

Salpingectomy

Part 2 consists of incorporating opportunistic salpingectomy /OS into non-gynecologic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Part I

* Age ≥45 years
* Scheduled visit with a nongynecologic surgeon
* Female or assigned female at birth

Part II

* Age ≥45 years
* At least one in situ fallopian tube
* No desire or plan to have children in the future
* Average risk of developing ovarian cancer

° Note: Average risk patients are defined as patients with no known genetic risk factor for developing ovarian cancer. Patients who, after obtaining family history, are suspected to have a hereditary ovarian cancer syndrome but have not yet been tested, will be referred for genetic evaluation.
* Planned nongynecologic, intraabdominal, or pelvic surgery
* Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologic surgeon (for example, on the basis of surgical history and current malignancy status)
* Approved and signed informed consent

Exclusion Criteria

Part I

* Not fluent in English or Spanish

° If there is a non-english or non-spanish speaking participant who is a strong candidate and meets all other criteria for Part 2, they are able to go directly onto Part 2 without completing Part 1. (Please see additional details in section 4.1 and 7.0.)
* Known inherited ovarian cancer susceptibility

Part II

* Personal history of a gynecologic malignancy
* Carrier of a hereditary breast or ovarian cancer variant (e.g., BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2)
* Suspicious ovarian, fallopian tube, or uterine lesion on preoperative imaging
* Previous bilateral salpingectomy or bilateral salpingo-oophorectomy
* Presence of ESSURE, or other tubal-implanted birth control at the time of surgery
* Current pregnancy
* Emergent procedure or emergency procedure that has to be completed within 24 hours where clinical consent occurs in the inpatient setting or where the patient's immediate well-being is in danger or condition may be life threatening
* Primary surgeon anticipates that OS will add significant time (\>30-40min) to the planned procedure.
* Inability to access the pelvis (ex., patient prone/lateral position) during the planned procedure.
* Known history of pelvic fibrosis or significant adhesions.
* Procedures with palliative intent only

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes