Feasibility of Opportunistic Salpingectomy During Non-Gynecologic Surgery

Ovarian Cancer Clinical Trial

Official title:

Feasibility of Opportunistic Salpingectomy During Non-Gynecologic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04176484
• Other study ID #: 22001
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2019
• Source: University of Virginia
• Contact: Ian C Cook, MD
• Phone: 4349821719
• Email: ic8ft[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is now felt that the majority of ovarian cancers originate in the fallopian tubes. Opportunistic salpingectomy has been found to decrease ovarian cancer risk by approximately 65%, with additional removal of the ovaries decreasing risk up to 98%. Using data collected under IRB #21841 and a population based statistics model we found that performing opportunistic salpingectomy during non-gynecologic abdominal surgery could decrease the incidence of ovarian cancer by 28-38%.

Description:

The purpose of this study is to:

1. gauge patient interest and

2. evaluate the feasibility of offering opportunistic salpingectomy or salpingo-oophorectomy to women undergoing non-gynecologic surgery at UVA medical center.

Data for this study will be collected in two different ways:

Part 1: Women, 18 years of age or older, who are scheduled for an abdominal procedure after being seen in the General Surgery clinic will be given a handout (attached) by clinic staff during routine pre-op counseling informing them that they may be called and asked to participate in a research survey. Women age 25 and above who are scheduled for an abdominal procedure and were seen in the General Surgery Clinic will be called and asked to complete a 5-10 minute verbal survey prior to their date of surgery. Some additional information will be gleaned from the medical record during the interview. Participation will be voluntary and all data collected will be recorded without any identifiers.

Part 2: A list of women 25 or older who are scheduled for an abdominal procedure after being seen in the General Surgery clinic will be generated to include MRN, procedure date, and pocedure type. A medical record review will be undertaken of these women and we will collect information about conditions that would facilitate or hinder the ability to perform a salpingectomy. No patient interaction will occur by the study team and all data will be de-identified at the time of collection. Data collected during this chart review will be linked and coded. Only coded data will be used during analysis. A separate password protected/encrypted file will contain the patient identifiers and the key to the coded sample numbers. This file will only be accessible by the PI or study team listed on this protocol on UVa premises, and will only be stored on a UVa server behind the UVa firewall, and will not be stored or accessed on personal computers. Thus, identified patient information will not be accessible to any individual, except the PI or study team listed on this protocol, ensuring protection of patient information

Study data will be analyzed to evaluate for acceptance of the program and acceptance of the mode of approaching the patient for counseling/consent. The frequency and types of conditions that hinder the ability to perform the suggested procedure will also be analyzed to determine how frequently the eligible population could receive a salpingectomy if a program was implemented.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18 for Group 1

• over 25 for Group 2

Exclusion Criteria:

• male

• under 18 for Group 1

• under 25 for Group 2

• inability to give verbal consent

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Survey
Women age 25 and above who are scheduled for an abdominal procedure and were seen in the General Surgery Clinic will be called and asked to complete a 5-10 minute verbal survey prior to their date of surgery. Some additional information will be gleaned from the medical record during the interview.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Acceptability from patients of opportunistic salpingectomy	based on responses to questionnaire , Likert scale of 1-5 with 1 low and 5 as high	1 year