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NCT03281564 Clinical Trial

Quality of Life After Laparoscopic Removal of Essure®

Quality of Life Clinical Trial

— ABLIMCO  

Official title:
Prospective Study of Quality of Life After Laparoscopic Removal of Essure®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03281564
Other study ID # 69HCL17_0479
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 14, 2017
Est. completion date October 17, 2023

Study information
Verified date May 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Quality of life after Essure® removal
Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device

Locations
Country Name City State
France Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
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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