Quality of Life Assessment Before and After Essure Removal

Patients Presenting Essure Device Attributed Symptoms Clinical Trial

— ESSURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401437
• Other study ID #: RECHMPL17_0154
• Status: Completed
• Start date: January 10, 2017
• Est. completion date: November 16, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 16, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Presenting Essure Device Attributed Symptoms

Intervention

Behavioral:
• SF-36
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
• HAD
Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.

Other:
• ANSM
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.

Locations

Country	Name	City	State
France	Public Assistance - Marseille Hospitals	Marseille
France	Montpellier University Hospital	Montpellier

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Aix Marseille University, La Conception Hospital - Marseille - France, Public Assistance - Marseille Hospitals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	General disorders and anxiety or depression	General disorders and anxiety or depression (by questionnaire HAD)	One month before surgery and 3 months after surgery.
Secondary	Performance of 3D ultrasound	Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively	Preoperatively
Secondary	Allergy to components	Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests	Before removing the sterilization devices (Essure®)
Secondary	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
Secondary	Defects in installation or secondary migration	Estimate the prevalence of Essure® deposition or secondary migration defects	during surgery