Prospective Study of Quality of Life After Laparoscopic Removal of Essure®

Hospices Civils de Lyon1 site in 1 country474 target enrollmentOctober 14, 2017

ConditionsContraceptive Device; Complications Quality of Life

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Contraceptive Device; Complications
Sponsor: Hospices Civils de Lyon
Enrollment: 474
Locations: 1
Primary Endpoint: Quality of life 1 month after laparoscopic removal of Essure®
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 14, 2017

End Date

October 17, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

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.