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It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essure | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pro-inflammatory cytokines | Other | compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis. |
| Measure | Description | Time Frame |
|---|---|---|
| cytokine IL10 in peritoneal fluid | Level of cytokine IL10 in peritoneal fluid | through study completion, an average of 4 months |
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Inclusion Criteria:
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:
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This study focuses on patients who underwent surgery to remove the Essure® contraceptive implant and on control patients who underwent benign gynecological laparoscopic surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon | Bron | 69500 | France |
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