Quality of Life Assessment Before and After Essure Removal

Study Overview
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Brief Summary
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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.

Detailed Description
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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): a prospective part having received a favorable opinion from a Committee for the Protection of Persons, and a retrospective part having received a favorable opinion from the Institutional Review Board (IRB), local ethics committee 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.

Official Title
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Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study

Conditions
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Patients Presenting Essure Device Attributed Symptoms

Intervention / Treatment
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* Behavioral: SF-36
* Behavioral: HAD
* Other: ANSM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients carrying Essure® Patients requesting surgical removal of Essure® Patients with adverse effect Being affiliated or benefiting from a French social security system Exclusion Criteria: - Patients with guardianship or curators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohorte<br>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<br>Patients seen in consultation between August 2017 | Behavioral: SF-36<br>* 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<br>* Other names: Short Form 36 Health Survey questionnaire;Behavioral: HAD<br>* Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.<br>* Other names: Hospital Anxiety and Depression scale;Other: ANSM<br>* 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.<br>* Other names: ANSM questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adverse effects, Salpingectomy, Essure® device ablation, Cornual resection