Study Results
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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UNKNOWN
150 participants
OBSERVATIONAL
2022-11-01
2023-12-30
Brief Summary
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The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.
Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.
The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Essure
patient who underwent removal of the Essure® contraceptive implant
pro-inflammatory cytokines
compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.
Control with no endometriosis/adenomyosis
patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
pro-inflammatory cytokines
compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.
Control with endometriosis/adenomyosis
patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis
pro-inflammatory cytokines
compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.
Interventions
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pro-inflammatory cytokines
compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.
Eligibility Criteria
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Inclusion Criteria
* intervention between January 2021 and November 2022
* person having expressed his non-opposition
Essure group : patient who underwent removal of the Essure® contraceptive implant
Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis
Exclusion Criteria
* person deprived of liberty
* person under guardianship
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
Bron, , France
Countries
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Other Identifiers
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69HCL23_0557
Identifier Type: -
Identifier Source: org_study_id
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