Contraceptive Device; Complications, Quality of Life
Conditions
Brief summary
A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.
Interventions
OTHERQuality of life after Essure® removal
Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device
Sponsors
Hospices Civils de Lyon
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women aged 18 years or more * patients with Essure® sterilization device * surgical removal of Essure® with bilateral salpingectomy by laparoscopy
Exclusion criteria
* interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc. * impaired lower-limb range of motion preventing positioning for surgery * inability to understand information provided * prisoner or under administrative supervision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life 1 month after laparoscopic removal of Essure® | 1 month | Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device |
Countries
France
Outcome results
None listed