Quality of Life After Laparoscopic Removal of Essure® (ABLIMCO)

Civil Hospices of Lyon

Status: Completed

Conditions: Contraceptive Device; Complications; Quality of Life

Treatments: Other: Quality of life after Essure® removal

Study type: Observational

Funder types: Other

Identifiers

NCT03281564

69HCL17_0479

Details and patient eligibility

About

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.

Enrollment: 474 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

474 participants in 1 patient group

Essure®

Description:

Patients with laparoscopic removal of Essure®

Treatment:

Other: Quality of life after Essure® removal