Quality of Life After Laparoscopic Removal of Essure®

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.

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Key information

Conditions

Contraceptive Device; Complications Quality of Life

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of life after Essure® removal

Other

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

Primary outcomes

Quality of life 1 month after laparoscopic removal of Essure®

Time frame: 1 month

Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ABLIMCO

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Sep 13, 2017
Registry last updated: Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed