Quality of Life After Laparoscopic Removal of Essure®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

474 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-14

Study Completion Date

2023-10-17

Brief Summary

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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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Detailed Description

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Conditions

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Contraceptive Device; Complications Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Essure®

Patients with laparoscopic removal of Essure®

Quality of life after Essure® removal

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No