Clinical trial NCT03401437: Quality of Life Assessment Before and After Essure Removal
Official title: Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Presenting Essure Device Attributed Symptoms
Keywords: adverse effects
Salpingectomy
Essure® device ablation
Cornual resection
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: La Conception Hospital - Marseille - France
name: Public Assistance - Marseille Hospitals
name: Aix Marseille Université
First posted: 2018-01-17
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with definitive sterilization by Essure®

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improving the quality of life between pre and post-operative at 3 months
timeFrame: 3 months after the surgery
Secondary outcomes:
measure: General disorders and anxiety or depression
timeFrame: One month before surgery and 3 months after surgery.
measure: Performance of 3D ultrasound
timeFrame: Preoperatively
measure: Allergy to components
timeFrame: Before removing the sterilization devices (Essure®)
measure: Allergy to components
timeFrame: During surgical removal
measure: Defects in installation or secondary migration
timeFrame: during surgery
Other outcomes:
Locations:
city: Marseille
country: France
facility: Public Assistance - Marseille Hospitals
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: PATRICE PC CROCHET, PhD
role: STUDY_DIRECTOR
References: