Quality of Life Assessment Before and After Essure Removal

Completed

• Conditions: Patients Presenting Essure Device Attributed Symptoms
• Interventions: Behavioral: SF-36; Behavioral: HAD; Other: ANSM

• Registration Number: NCT03401437
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2017-01-10
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-17
• Primary Completion: 2018-01-31
• Study Completion: 2018-11-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohorte	HAD	Patients seen in consultation between August 2017
Prospective cohorte	ANSM	Patients seen in consultation between August 2017
Prospective cohorte	SF-36	Patients seen in consultation between August 2017

Primary Outcome Measures

Name	Time	Method
Improving the quality of life between pre and post-operative at 3 months	3 months after the surgery	The quality of life is measure with Short Form (36) Health Survey Questionnaire

Secondary Outcome Measures

Name	Time	Method
General disorders and anxiety or depression	One month before surgery and 3 months after surgery.	General disorders and anxiety or depression (by questionnaire HAD)
Allergy to components	During surgical removal	Reaction to metals: to estimate the prevalence of Nickel release by the Essure® , by the analysis of the surgical parts
Defects in installation or secondary migration	during surgery	Estimate the prevalence of Essure® deposition or secondary migration defects
Performance of 3D ultrasound	Preoperatively	Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively

Trial Locations

Locations (2)

Montpellier University Hospital; 🇫🇷 Montpellier, France

Public Assistance - Marseille Hospitals; 🇫🇷 Marseille, France