56 Chapter 4 written consent was obtained from enrolled participants before their inclusion in the study. Consenting participants received at least one month before the study visit two standardized questionnaires: 1. PBAC to examine blood loss and dysmenorrhea and 2. Short Form-36 survey (SF-36) to determine the women’s QoL (7, 14, 15). Participants were asked to complete the questionnaires at home and submit it to the study team members during a study visit at our outpatient clinic. During this study visit the ISTH-BAT questionnaire was administered face-to-face between a participant and a gynecologist specializing in bleeding disorders in women (4). The ISTH-BAT scores were double-checked by a second clinician, also familiar with bleeding disorders in women. The PBAC and ISTH-BAT scores were not determined prior to initial EA treatment because it was not standard care in our outpatient clinic. At 10 years follow-up an additional medical chart review took place to evaluate the number of surgical re-interventions (Figure 1). Figure 1: (Heavy Menstrual Bleeding (HMB); International Society on Thrombosis and Haemostasis-Bleeding Assessment Tool (ISTH-BAT); pictorial bleeding assessment chart (PBAC);The 36-item short-form health survey (SF-36)) surgical reintervention rate (repeat EA, hysterectomy) at 10 years follow-up. Secondary, major intraoperative bleeding complications were retrospect evaluated by reviewing the medical charts at 10 years followup. Each outcome was assessed in women with possible bleeding disorders (ISTH-BAT ≥6 score) versus women without possible bleeding disorders (ISTH-BAT <6). Local endometrial ablation procedures All EA procedures were performed with a second-generation bipolar radio-frequency impedancecontrolled endometrial ablation device (NovaSure®, Hologic, Marlborough, USA). (16) Exclusion criteria for EA treatment in our hospital are age <18 years, presence of intracavitary fibroids, Written consent to participate (n=88) Women ≥18 years referred for HMB and treated with EA between January 2010 and January 2014 at the Department of Gynaecology, Gelre Hospitals Apeldoorn identified patient administrative system (treatment code G11: menstrual cycle disorders) (n=253) Identification Screening Eligibility Included Analyzed (n=71) ISTH BAT ≥6 (n=16) ISTH BAT <6 (n=55) Excluded (n=165) Not willing to participate Assessments: Intra-operative bleeding complications 2-5 years after EA: ISTH-BAT, dysmenorrhea, PBAC, SF-36 Within 10 years after EA: Surgical re-intervention Exclusion due to incomplete data (n= 17)
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