Quality of Life After Laparoscopic Removal of Essure®
Completed
- Conditions
- Contraceptive Device; ComplicationsQuality of Life
- Interventions
- Other: Quality of life after Essure® removal
- Registration Number
- NCT03281564
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 474
Inclusion Criteria
- women aged 18 years or more
- patients with Essure® sterilization device
- surgical removal of Essure® with bilateral salpingectomy by laparoscopy
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Essure® Quality of life after Essure® removal Patients with laparoscopic removal of Essure®
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
🇫🇷Bron, France