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| Name | Class |
|---|---|
| La Conception Hospital - Marseille - France | UNKNOWN |
| Public Assistance - Marseille Hospitals | UNKNOWN |
| Aix Marseille Université | OTHER |
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To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.
Tubal sterilization is a widely used method of contraception. The hysteroscopic sterilization method (Essure®; Bayer, Germany) was approved in 2007 in France. Increasing patients reports of complications, such as bleeding pain, allergies, fatigue or articular pain have raised concerns about the safety device. Women suffering of alleged complications of the Essure® device ask for surgical removal. But, only few studies have assessed Essure® removal in terms of quality of life. This observational study contains two parts will be conducted at two academic tertiary care center (Montpellier - Marseille):
Patients: Women requesting surgical management for removal of Essure® for alleged adverse effects.
Assessment tools :
Quality of life with the Short Form 36 (SF-36) Health Survey questionnaire (pre-operatively and at 1 and 3 months) Hospital Anxiety and Depression (HAD) scale (pre-operatively and 3 months)
Preoperative imaging, procedure characteristics, including the Essure® removal method, operative findings, perioperative complications, histopathologic report, and length of hospital stay will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohorte | Patients seen in consultation between January 2017 and August 2017, who have already completed the SF-36 questionnaire (pre-operative, M1 and M3), the HAD and ANSM questionnaires (pre-operative and M3) | ||
| Prospective cohorte | Patients seen in consultation between August 2017 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SF-36 | Behavioral | Evaluation of the quality of life with an auto-questionnaire validated, with 8 dimensions: physical activity ; limitations due to physical condition; physical pain; perceived health; vitality; life and relationship with others; limitations due to physical condition; psychic health as well as the assessment of perceived health compared to a year ago. Evaluation done pre-operatively, at M1 and M3 |
| Measure | Description | Time Frame |
|---|---|---|
| Improving the quality of life between pre and post-operative at 3 months | The quality of life is measure with Short Form (36) Health Survey Questionnaire | 3 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| General disorders and anxiety or depression | General disorders and anxiety or depression (by questionnaire HAD) | One month before surgery and 3 months after surgery. |
| Performance of 3D ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with guardianship or curators
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Patient with definitive sterilization by Essure®
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| Name | Affiliation | Role |
|---|---|---|
| PATRICE PC CROCHET, PhD | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Assistance - Marseille Hospitals | Marseille | 13005 | France | |||
| Montpellier University Hospital |
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| ID | Term |
|---|---|
| C018209 | 4-amino-4'-hydroxylaminodiphenylsulfone |
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| HAD | Behavioral | Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3. |
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| ANSM | Other | Additional information requested by the ANSM (french National Agency for Medicines and Health Products Safety) following a materiovigilance report. Evaluation done pre-operatively and at M3. |
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|
Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively
| Preoperatively |
| Allergy to components | Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests | Before removing the sterilization devices (Essure®) |
| Allergy to components | Reaction to metals: to estimate the prevalence of Nickel release by the Essure® , by the analysis of the surgical parts | During surgical removal |
| Defects in installation or secondary migration | Estimate the prevalence of Essure® deposition or secondary migration defects | during surgery |
| Montpellier |
| 34295 |
| France |