Quality of Life Assessment Before and After Essure Removal (ESSURE)

University Hospital Center (CHU)

Status: Completed

Conditions: Patients Presenting Essure Device Attributed Symptoms

Treatments: Other: ANSM; Behavioral: SF-36; Behavioral: HAD

Study type: Observational

Funder types: Other

Identifiers

NCT03401437

RECHMPL17_0154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

95 participants in 2 patient groups

Retrospective cohorte

Description:

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

Description:

Patients seen in consultation between August 2017

Treatment:

Behavioral: HAD

Behavioral: SF-36

Other: ANSM