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

January 3, 2019 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Public Assistance - Marseille Hospitals
      • Montpellier, France, 34295
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient with definitive sterilization by Essure®

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective cohorte
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
Patients seen in consultation between August 2017
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
Other Names:
  • Short Form 36 Health Survey questionnaire
Behavioral: 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 Names:
  • Hospital Anxiety and Depression scale
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.
Other Names:
  • ANSM questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improving the quality of life between pre and post-operative at 3 months
Time Frame: 3 months after the surgery
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
Time Frame: One month before surgery and 3 months after surgery.
General disorders and anxiety or depression (by questionnaire HAD)
One month before surgery and 3 months after surgery.
Performance of 3D ultrasound
Time Frame: Preoperatively
Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively
Preoperatively
Allergy to components
Time Frame: Before removing the sterilization devices (Essure®)
Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests
Before removing the sterilization devices (Essure®)
Allergy to components
Time Frame: During surgical removal
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
Time Frame: during surgery
Estimate the prevalence of Essure® deposition or secondary migration defects
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Aix Marseille Université
La Conception Hospital - Marseille - France
Public Assistance - Marseille Hospitals

Investigators

  • Study Director: PATRICE PC CROCHET, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2017

Primary Completion (ACTUAL)

January 31, 2018

Study Completion (ACTUAL)

November 16, 2018

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

January 15, 2018

First Posted (ACTUAL)

January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL17_0154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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