Feasibility of Opportunistic Salpingectomy During Non-Gynecologic Surgery

NCT04176484 | Unknown DMC

• 1 other identifier: 22001
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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%.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; Opportunistic salpingectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Survey

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.

Other: Survey

Operating Room Feasibility

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.

Interventions

Survey OTHER

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.

Survey

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Salpingectomy is a surgery only done on women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing scheduled abdominal surgery

You may qualify if:

• over 18 for Group 1
• over 25 for Group 2

You may not qualify if:

• male
• under 18 for Group 1
• under 25 for Group 2
• inability to give verbal consent

Sponsors & Collaborators

• University of Virginia: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Ian C Cook, MD

CONTACT

4349821719; ic8ft@hscmail.mcc.virginia.edu

Charles N Landen, MD

CONTACT

434-924-9333; CL3NJ@hscmail.mcc.virginia.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share