Quality of Life Clinical Trial
— ABLIMCOOfficial title:
Prospective Study of Quality of Life After Laparoscopic Removal of Essure®
Verified date | May 2023 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 474 |
Est. completion date | October 17, 2023 |
Est. primary completion date | October 17, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon | Bron |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life 1 month after laparoscopic removal of Essure® | Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device | 1 month |
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