Observational Study Rheumatological Manifestations Associated With Endometriosis
ENDOMETRIOS
1 other identifier
observational
100
1 country
1
Brief Summary
Endometriosis is defined as the presence of endometriotic tissue outside the uterus. Its pathophysiology is still misunderstood today, but more and more work on this pathology are published. The clinical presentation is generally characterized by the existence of cyclical pelvic pain, with dysmenorrhea, dyspareunia, dysuria, dyschezia. But, there are a wide variety of symptoms, with different painful sites and different types of pain. The estimated prevalence of endometriosis is about 10% in women. But the impact of this disease on quality of life and its economic impact is estimated considerable. In a US study, the direct costs associated with endometriosis were estimated at US $ 2.801 per woman. Some studies have focused also to quantify work absenteeism associated with endometriosis. The etiology of endometriosis is based on the migration of endometrial fragments reaching the pelvis via the tubes and establishing themselves on other sites, thus creating non cyclical uterine pain. Catamenial pace of pain is suggestive of the diagnosis, but with time, the pain tends to be chronic rather than cyclical. The standard diagnosis is based on visualization and histological examination of the lesions. The wide variety of symptoms of endometriosis often leads to wandering and medical diagnostic delay. A better understanding of this disease by the medical community would allow better management of these patients. Currently, endometriosis remains a misunderstood disease by rheumatologists. However, the initial presentation may mimic rheumatologic symptoms; thus, rheumatologists may face this disease. The purpose of this study was to determine the prevalence and characteristics of manifestations of endometriosis in a cohort of patients with a recent diagnosis of endometriosis established. Secondly, it may well be possible to establish a list of symptoms and signs suggestive of endometriosis for the rheumatologist, allowing to contact a specialized consultant gynecologist some patients "by mistake" in rheumatology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedJuly 11, 2016
July 1, 2016
6 months
July 6, 2016
July 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Endometriosis stage
According to the classification of the AFS (American Fertility Society)
Day 1
Secondary Outcomes (2)
Rheumatic stage
Day 1
Analogic Pain Evaluation
Day 1
Interventions
Patients consultant in gynecology in the service of Doctor Sauvanet, for whom a diagnosis of endometriosis has been established (clinical history and imaging tests confirming the diagnosis) will be offered to fill a self-administered questionnaire during their consultation
Eligibility Criteria
Women with endometriosis diagnosis established and confirmed consulting at St. Joseph Hospital.
You may qualify if:
- Women with endometriosis diagnosis established and confirmed at St. Joseph Hospital.
You may not qualify if:
- aged \<18 yo and menopause or aged \>50 yo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PORTIER Agnes, MD
Fondation Hôpital Saint-Joseph
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 11, 2016
Study Start
November 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 11, 2016
Record last verified: 2016-07