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Re-Essure study


- candidate number26465
- NTR NumberNTR6531
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2017
- Secondary IDsN16.081  METC
- Public TitleRe-Essure study
- Scientific TitleRe-Essure study; a observational study for adverse advents after hysteroscopic Essure sterilization
- ACRONYM
- hypothesis1) Several symptoms will not improve after removal. 2) Symptoms are similar to other tubal occlusion methods
- Healt Condition(s) or Problem(s) studiedSterillisation, Implants, Hysteroscopy
- Inclusion criteriaAll women with Essure implants
- Exclusion criteriaWomen who do not want to participate
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate31-dec-2019
- Target number of participants3000
- InterventionsParticipating women receive 4 questionnaires. The first will be send after their first visit followed by a second two months after the first visit to evaluate change in symptoms over time. The third and fourth form will be sent three and twelve months after the procedure. Ultrasound, X-ray and surgical findings will be registered before and during surgery. Women who decide to keep their Essure® will receive the questionnaires after their first visit, 3 and 12 months subsequently. The questionnaires contain a case report form (CRF) and QoL (using SF-36). The CRF will focus on complaints. Physicians will fill out 2 forms concerning pre- and perioperative data.
- Primary outcomesymptom reduction at 12 months after removal.
- Secondary outcomeQuality of life (SF36) and satisfaction.
- Timepoints• Inclusion phase prospective trial: cohort study 1; 3000 patients (expected to be 2.5 years) and cohort study 2 will be executed in parallel during the first year: Gynecologists, research nurses and researchers.
• Follow-up phase (12 months)
• Analytic phase (6 months) Analysis and report: researchers
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES DM van Gastel
- CONTACT for SCIENTIFIC QUERIESDr. Marlies Bongers
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryBACKGROUND: Increasing number of symptomatic women request for Essure removal. RESEARCH QUESTIONS: 1) Are symptoms reversed after Essure removal? 2) Are symptoms comparable to other tubal occlusion methods? HYPOTHESIS: 1) Several symptoms will not improve after removal. 2) Symptoms are similar to other tubal occlusion methods. STUDY DESIGN: A prospective multicenter cohort study consisting of two parts STUDY POPULATION: 1) All women requesting for Essure removal. 2) Women who received any tubal occlusion method. FOLLOW-UP: 1) 2 times before, 3 and 12 months after removal. 2) A single questionnaire. OUTCOMES: 1) Primary: symptom reduction at 12 months after removal. Secondary: QOL (SF36) and satisfaction. SAMPLE SIZE/DATA-ANALYSIS: 1) Estimated 3000 women. 2) 600. 1) McNemar’s test will be used to test changes in occurrence of symptoms after removal and paired T-test for change in QOL. 2) Analysis of covariance and Chi square to compare QOL and symptoms after various occlusion methods.
- Main changes (audit trail)
- RECORD11-jan-2017 - 15-jul-2017


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