NCT Number: NCT03401437
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.
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Notify Me18 year and older
Female
Observational
Public Assistance - Marseille Hospitals, Marseille, France
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):
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: 3 months after the surgery
The quality of life is measure with Short Form (36) Health Survey Questionnaire
Time frame: One month before surgery and 3 months after surgery.
General disorders and anxiety or depression (by questionnaire HAD)
Time frame: Preoperatively
Estimate the performance of preoperative 3D ultrasound to identify a poor implantation of the Essure® found in Preoperatively
Time frame: Before removing the sterilization devices (Essure®)
Reaction to metals: Estimate the prevalence of contact allergy to components through skin tests
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
Time frame: during surgery
Estimate the prevalence of Essure® deposition or secondary migration defects
University Hospital, Montpellier
Other
Quality of Life Assessment of Women Undergoing Laparoscopic Removal of Essure System : a Before-and-after Study
Acronym: ESSURE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
