HYSTERECTOMY AND DYSFUNCTIONAL UTERINE BLEEDING

描述：这项研究是一项随机临床试验，将比较 子宫切除术、子宫内膜消融术的患者结局和相对成本 促性腺激素释放激素(GnRH)激动剂治疗(3个月GnRH 然后服用21个月的口服避孕药) 难治性功能性子宫出血。该项目将研究125名女性 三个试验性武器中的每一个。 受试者将从目前使用的临床人群中选择 来自卫生保健组织和私人的三个临床站点和/或转诊 从业者。研究地点是明尼阿波利斯的临床中心 伊利诺伊大学的HealthPartners和亨利·福特健康系统。 纳入标准为诊断为子宫功能障碍的患者。 出血者：绝经前，已生育完毕，并有 口服避孕药、孕激素或非类固醇的先前尝试失败 消炎剂。排除的标准是：禁忌症 子宫切除等并存状态很可能引起类似症状 (例如，子宫内膜异位症、盆腔炎、子宫内膜息肉、 子宫平滑肌瘤，或存在重大医疗问题，如 严重冠心病或慢性阻塞性肺疾病，多发性 曾做过腹部手术且有并发症)；GnRH的禁忌症 激动剂、雌激素或孕激素治疗(例如，严重既往 骨质疏松症、血栓栓塞症、慢性肝病)；吸烟10岁以上 每天吸烟；有记录的冠状动脉疾病；禁忌症 子宫内膜消融术如重度宫颈狭窄、子宫内膜 子宫内膜活检有不典型增生或瘤变；或可能 两年内不能遵循研究方案。 受试者将按临床中心和年龄进行随机分组。 (45岁以下、45岁或以上)。为了增加……的可能性 干预组的特征将具有可比性 协议，对医生的分层也将被考虑。这项研究 为期5年--包括9个月的计划、培训和 执行；18个月用于征聘；24个月用于后续行动 征聘结束；9个月用于数据分析和手稿 准备工作。数据收集和主题跟踪将在以下时间进行 开始治疗后的三个月间隔，根据 指定的手臂。将有一段时间的体检和简短的体检 检查(血压、脉搏、乳房、腹部和盆腔 除了12个月和24个月的实验室检查外，还需要进行检查)。 关于健康状况结果、特定患者结果的信息 关注有功能失调性子宫出血的妇女，以及 卫生系统和病人将被收集。有待评估的结果 将包括功能状态和与健康相关的生活质量、性 功能、发病率/副作用和成本。另一个重要目标是 该项目将详细说明临床结果，包括频率和持续时间。 GnRH激动剂的症状、副作用和失败率 长期口服避孕药。

DESCRIPTION: This study is a randomized clinical trial which will compare patient outcomes and relative costs of hysterectomy, endometrial ablation, and gonadotropin releasing hormone (GnRH) agonist therapy (3 months GnRH followed by oral contraceptives for 21 months) for women presenting with refractory dysfunctional uterine bleeding. The project will study 125 women in each of three trial arms. Subjects will be chosen from the clinic populations which presently use one of three clinical sites and/or referrals from the HMO and private practitioners. Study sites are the clinical centers at Minneapolis HealthPartners, University of Illinois, and Henry Ford Health System. Subject inclusion criteria are those with diagnosed dysfunctional uterine bleeding who are: premenopausal and have completed childbearing, and have failed prior attempts with oral contraceptives, progestins, or non-steroidal anti-inflammatory agents. The exclusion criteria are: contraindication to hysterectomy such as coexistent condition likely to cause similar symptoms (e.g., endometriosis, pelvic inflammatory disease, endometrial polyps, leiomyomata uteri, or presence of a significant medical problem such as severe coronary heart or chronic obstructive pulmonary disease, multiple prior abdominal surgeries with complications); contraindication to GnRH agonist, estrogen, or progestin therapy (e.g., severe preexistent osteoporosis, prior thromboembolism, chronic liver disease); smoking over 10 cigarettes per day; documented coronary artery disease; contraindication to endometrial ablation such as severe cervical stenosis, endometrial hyperplasia with atypia or neoplasia on endometrial biopsy; or likely inability to follow the study protocol for two years. Subjects will be randomized and stratified by clinical center and by age (less than 45 years, 45 years or older). To increase the likelihood that the intervention groups will be comparable on the characteristics in the protocol, stratification on physician will also be considered. The study duration is 5 years -- including 9 months for planning, training, and implementation; 18 months for recruitment; 24 months for follow-up beyond the end of recruitment; and 9 months for data analysis and manuscript preparation. Data collection and subject follow-up will occur at three-month intervals after initiation of treatment, according to the assigned arm. There will be an interval medical and brief physical examination (blood pressure, pulse, breast, abdominal, and pelvic examination), in addition to laboratory tests at 12 and 24 months. Information on health status outcomes, specific patient outcomes which concern women who have dysfunctional uterine bleeding, and costs to both the health system and the patient will be collected. Outcomes to be evaluated will include functional status and health-related quality of life, sexual function, morbidity/side effects, and cost. An additional important aim of the project is to detail clinical outcomes, including frequency and duration of symptoms, side effects, and rate of failure of GnRH agonist followed by long-term oral contraceptive therapy.