Quality of Life After Laparoscopic Removal of Essure®

Hospices Civils de Lyon474 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

474

Conditions

Contraceptive Device; Complications Quality of Life

Interventions

Quality of life after Essure® removalOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Bron, France

Outcomes

Primary Outcomes

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

Time frame: 1 month

Data from ClinicalTrials.gov

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