Study Results
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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UNKNOWN
90 participants
OBSERVATIONAL
2021-01-01
2021-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* symptoms related to ESSURE device
* salpingectomy for ESSURE removal
18 Years
FEMALE
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Martha DURAES, Md
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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Uhmontpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RECHMPL21_0087
Identifier Type: -
Identifier Source: org_study_id
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