HYSTERECTOMY AND DYSFUNCTIONAL UTERINE BLEEDING

描述：本研究是一项随机临床试验， 子宫切除术，子宫内膜切除术， 促性腺激素释放激素（GnRH）激动剂治疗（3个月GnRH 随后口服避孕药21个月）， 难治性功能失调性子宫出血。 该项目将研究125名妇女 在三个试验组中的每一个中。 受试者将从目前使用的临床人群中选择 三个临床站点和/或从HMO和私人转诊 从业者 研究中心为明尼阿波利斯的临床中心 健康伙伴，伊利诺伊大学和亨利福特健康系统。 受试者入选标准为诊断为子宫功能障碍的受试者 出血患者：绝经前和已完成生育， 既往口服避孕药、孕激素或非甾体类药物尝试失败 抗炎剂。 排除标准为：禁忌症 子宫切除术，如共存条件可能导致类似症状 (e.g.,子宫内膜异位症，盆腔炎，子宫内膜息肉， 子宫平滑肌瘤，或存在重大医学问题，如 重度冠心病或慢性阻塞性肺病，多发性 既往腹部手术并发症）; GnRH禁忌症 激动剂、雌激素或孕酮治疗（例如，严重先存 骨质疏松症、既往血栓栓塞、慢性肝病）;吸烟超过10 每日吸烟量;有记录的冠状动脉疾病;禁忌症 子宫内膜切除术，如严重宫颈狭窄，子宫内膜 子宫内膜活检显示增生伴子宫内膜瘤或瘤形成;或可能 无法遵循研究方案两年。 受试者将按临床试验机构和年龄进行随机化和分层 (less 45岁或以上）。 为了增加 干预组在以下特征上具有可比性： 方案，还将考虑对医生进行分层。 研究 为期5年，包括9个月的规划、培训和 执行;征聘18个月;后续行动24个月 招募结束;以及9个月的数据分析和手稿 准备. 数据收集和受试者随访将在 治疗开始后3个月间隔，根据 分配的手臂。将有一个间隔医疗和简短的身体 检查（血压、脉搏、乳房、腹部和骨盆 检查），以及12个月和24个月时的实验室检查。 关于健康状况结局、特定患者结局的信息， 关注患有功能失调性子宫出血的妇女， 卫生系统和病人将被收集。 有待评价的成果 将包括功能状态和与健康相关的生活质量，性行为 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 的症状，副作用，和失败率的GnRH激动剂， 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.