Laparoscopic Essure Device Removal

Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04779658

Acronym

ESSURE

Enrollment

Registered

2021-03-03

Start date

2021-01-01

Completion date

2021-12-30

Last updated

2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Essure device removal, Quality of life

Brief summary

In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device. Study Objective: To evaluate the quality of life of patients who underwent Essure\_ device removal and morbidity of this surgery. Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France. Patients: Women who underwent Essure\_ device removal by salpingectomy, between February 2017 and August 2018. Methods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires. Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age \>18 years old * symptoms related to ESSURE device * salpingectomy for ESSURE removal

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of quality of life after ESSURE removal	Preoperative	Evaluation of quality of life after ESSURE removal by SF 36 questionnaire Preoperative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up

Secondary

Measure	Time frame	Description
Evaluation of morbidity of ESSURE removal	1 day	description of per et postoperative complications (patient's medical record and by phone call)

Countries

France

Contacts

Primary ContactGAUTHIER RATHAT

g-rathat@chu-montpllier.fr467336421

Backup ContactMartha DURAES, MD

duraesmartha@gmail.com631329158

Outcome results