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临床试验/NCT04176484
NCT04176484Unknown不适用

Feasibility of Opportunistic Salpingectomy During Non-Gynecologic Surgery

University of Virginia0 个研究点目标入组 150 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Feasibility and Acceptability from patients of opportunistic salpingectomy

研究概览

简要总结

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%.

详细描述

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Feasibility and Acceptability from patients of opportunistic salpingectomy

时间窗: 1 year

based on responses to questionnaire , Likert scale of 1-5 with 1 low and 5 as high

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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