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Faculty of Medical Sciences

GERINGE BEREIDHEID VAN MYOOMPATIËNTEN VOOR DEELNAME AAN EEN GERANDOMISEERDE STUDIE

Pol, R.L.I. (2019) GERINGE BEREIDHEID VAN MYOOMPATIËNTEN VOOR DEELNAME AAN EEN GERANDOMISEERDE STUDIE. thesis, Medicine.

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Abstract

Background In 2016 the non-invasive fibroid treatment Magnetic Resonance-High Intensity Focused Ultrasound (MR-HIFU) was introduced in Isala Hospital. Hitherto the effectiveness of this treatment has not been adequately compared with alternative treatments. Therefore, we investigated the willingness of patients with uterine fibroids to participate in a randomized controlled trial (RCT) in which MR-HIFU is compared with uterine artery embolization and hysterectomy. Secondly, we analyzed the clinical results (Non-Perfused Volume percentage (NPV%) and reintervention rate) of MR-HIFU treatments in Isala Hospital. Besides, the health-related quality of life after MR-HIFU treatment was evaluated. Material and methods During this study a survey was held among 170 patients who have been treated for uterine fibroids for assessing willingness to participate in a RCT. Patient characteristics and clinical results were obtained from medical charts. Patients treated with MR-HIFU were followed up during 12 months in which Uterine Fibroid Symptom and Quality of Life Questionnaires (UFS-QoL) were obtained. Results 11,8% of questionnaire responders (n=51) were willing to participate in a therapeutic RCT. This percentage increased to 25,4% if MR-HIFU therapy would only be available within a trial (p=0,016). For our secondary outcomes, we found a mean NPV% of 65,4% ± 30,5. The cumulative risk for re-intervention in our study population is 30% in a 40-month period after MR-HIFU therapy. Patients experienced a decrease in symptom severity and increase in quality of life during follow-up time (p<0,001). Conclusion Willingness to participate in a RCT is low among uterine fibroid patients. Willingness increases when MR-HIFU therapy is only available in a trial and is not part of regular treatment options. MR-HIFU therapy appears to be effective in reducing fibroid symptoms.

Item Type: Thesis (UNSPECIFIED)
Supervisor name: Schutte, J.M.
Supervisor name: Verpalen, I,M. and Brohet, R.M.
Faculty: Medical Sciences
Keywords: Isala
Date Deposited: 03 Jul 2020 11:41
Last Modified: 08 Jul 2020 07:52
URI: https://umcg.studenttheses.ub.rug.nl/id/eprint/2736

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