Characteristics of Patient Population With Endometriosis

NCT ID: NCT03002870

Last Updated: 2024-09-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2024-09-04

Brief Summary

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The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.

Detailed Description

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Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only).

A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed.

A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed.

Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.

Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endometriosis

Patients whom pathology results post surgery document endometriosis

Group Type OTHER

Questionnaires

Intervention Type OTHER

Patients will receive questionnaires yearly to follow their QOL

Interventions

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Questionnaires

Patients will receive questionnaires yearly to follow their QOL

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female patients
* 13-55 years of age
* Anyone seen at the Center for Endometriosis

Exclusion Criteria

* Prior bilateral salpingo-oophorectomy
* post natural menopause
* Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.
Minimum Eligible Age

13 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Patrick Yeung Jr., MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Yeung, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

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Saint Louis University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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20900

Identifier Type: -

Identifier Source: org_study_id

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