Observational Study Rheumatological Manifestations Associated With Endometriosis

NCT ID: NCT02826980

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-05-31

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.

Detailed Description

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.

Main objective / secondary:

Observational study rheumatological manifestations associated with endometriosis: prevalence and characteristics of rheumatological manifestations associated with endometriosis, via a self-administered questionnaire.

Methodology :

Design: Prospective, observational Time study: 3 to 6 months

Acquisition of data:

• Self-administered questionnaire (in PJ)
• Supports state and annex: FIU PJ, Excel grid of data collection.
• Statistical analysis Saint Joseph
• Clarify data anonymisation: not anonymisation, but confidentiality.

Development of the study:

• Describe how the study:

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 meet a self-administered questionnaire during their consultation. This will be delivered by the gynecologist in the consultation, with the consent sheet. If the patient agrees, the self-administered questionnaire must be completed in the consultation box or in the waiting room, and handed to the gynecologist or the secretary of the consultation.

Data will be collected and analyzed.

• Expected duration of patient recruitment: 3 months

Conditions

Rheumatology; Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

questionnaire

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women with endometriosis diagnosis established and confirmed at St. Joseph Hospital.

Exclusion Criteria

• aged <18 yo and menopause or aged >50 yo

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PORTIER Agnes, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

ENDOMETRIOS

Identifier Type: -

Identifier Source: org_study_id