Observational Study Rheumatological Manifestations Associated With Endometriosis

Endometriosis Clinical Trial

— ENDOMETRIOS  

Official title:

Observational Study Rheumatological Manifestations Associated With Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826980
• Other study ID #: ENDOMETRIOS
• Status: Completed
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 7, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis
• Rheumatology

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometriosis stage	According to the classification of the AFS (American Fertility Society)	Day 1	No
Secondary	Rheumatic stage	Radiographic stages of knee OA: 0 normal radiographic stage Stage 1 of questionable significance osteophytes Stage 2 net osteophytes without changing the joint line Stage 3 net decrease osteophytes and joint space Stage 4 Severe narrowing of the joint space and sclerosis of the subchondral bone.; Radiological stages of osteoarthritis: Stage 0 normal radiographic Stage 1 joint space narrowing, osteophytes doubtful péricapitale Stage 2 joint space narrowing, osteophytes, moderate bone sclerosis Stage 3 net joint space with discrete osteophytes, bone sclerosis with cyst deformation of the femoral head and acetabulum minimal Stage 4 dispariton joint space with bone sclerosis and cyst, significant deformation of the femoral head and the acetabulum, with major osteophytes.	Day 1	No
Secondary	Analogic Pain Evaluation	On a scale from 0 to 10	Day 1	No