Cleveland Clinic Clinical Site

克利夫兰诊所临床中心

基本信息

批准号：
8119834
负责人：
MATTHEW D BARBER
金额：
$ 33.76万
依托单位：
CLEVELAND CLINIC LERNER COM-CWRU
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-12 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8119834
关键词：
Accounting Anatomy Basic Science Biomedical Engineering Blinded Caring Clinic Clinical Clinical Research Clinical Sciences Clinical Trials Collaborations Colorectal Surgery Commit Conduct Clinical Trials Day Surgery Diagnosis Discipline Enrollment Environment Epidemiology Evaluation Female Gastrointestinal tract structure Goals Graduate Education Human Resources Hysterectomy Intervention Leadership Ligaments Lower urinary tract Morbidity - disease rate Operating Rooms Operative Surgical Procedures Organ Outcome Patients Pelvic Floor Disorders Pelvis Physical therapy Postmenopause Principal Investigator Procedures Ptosis Radiology Specialty Randomized Recording of previous events Recovery Rectal Prolapse Relative (related person)Reporting Research Research Infrastructure Research Methodology Research Personnel Resources Role Sensory Sexual Health Staging Study Subject Surgeon Surgical Management Symptoms Testing Time United States Urology Uterus Vagina Vaginal Hysterectomy Woman base clinical care clinical research site comparative effectiveness cost cost effective cost effectiveness design experience health related quality of life interest member postgraduate education sample fixation

项目摘要

DESCRIPTION (provided by applicant): The goal of the Pelvic Floor Disorders Network (PFDN) is to identify optimum diagnosis and management strategies for women with pelvic floor disorders (PFD) using the highest quality research methods available. The Cleveland Clinic offers a stable academic and research-oriented environment for the conduct of PFDN studies including experienced investigators with complementary clinical and research backgrounds that have a particular interest and a successful history of conducting clinical trials evaluating both surgical and nonsurgical therapies for women with PFD. The specific aims of this application are: 1) to demonstrate that the Cleveland Clinic (CC) Clinical Site has contributed substantially to the academic, administrative, and clinical aspects of the PFDN since joining in its 2nd 5-year cycle; that it possesses the personnel, patient, clinical and administrative resources needed for successful participation; and that continued participation would be advantageous to the successful attainment of the Network's scientific goals and 2) to present a concept proposal for potential conduct by the PFDN. We propose evaluating the comparative effectiveness of sacrospinous hysteropexy (SSH), the most well-studied uterine-sparing pelvic organ prolapse (POP) surgery, relative to total vaginal hysterectomy with sacrospinous ligament fixation (TVH/SSLF), a commonly used hysterectomy-based vaginal uterovaginal prolapse procedure. The specific aims of the concept proposal are: 1) compare the anatomic, functional, sexual and health-related quality of life outcomes of SSH to TVH/SSLF in women undergoing surgery for Stage 2-4 POP uterovaginal prolapse 2 years after surgery; 2) compare surgical recovery and short- and long-term morbidity of SSH and TVH/SSLF in these same women and 3) determine the incremental cost-effectiveness of SSH compared to TVH/SSLF for the treatment of Stage 2-4 POP. Enrolled subjects will be randomized in the operating room on the day of surgery to receive either SSH or TVH/SSLF (1:1) using a random permutated block design. Randomization will be stratified by surgeon to account for the varying experience and expertise. Subjects and study coordinators will be blinded to treatment assignment until completion of the study. RELEVANCE: Nearly one quarter of all women report symptoms of at least one PFD, including prolapse. POP is the most common indication for hysterectomy in postmenopausal women and it is unknown whether the addition of hysterectomy to POP surgery is integral to successful surgical outcome. The results of our concept proposal could justify or eliminate the need for as many as 70,000 hysterectomies in the US each year.

描述（由申请人提供）：盆底疾病网络 (PFDN) 的目标是使用现有的最高质量的研究方法为患有盆底疾病 (PFD) 的女性确定最佳诊断和管理策略。克利夫兰诊所为进行 PFDN 研究提供了稳定的学术和研究导向的环境，包括具有互补临床和研究背景的经验丰富的研究人员，他们对评估 PFD 女性手术和非手术治疗的临床试验有特别的兴趣和成功的历史。本申请的具体目标是： 1) 证明克利夫兰诊所 (CC) 临床中心自加入其第二个 5 年周期以来，对 PFDN 的学术、管理和临床方面做出了重大贡献；它拥有成功参与所需的人员、患者、临床和行政资源；继续参与将有利于成功实现网络的科学目标；2) 为 PFDN 的潜在行动提出概念提案。我们建议评估骶棘子宫固定术 (SSH)（研究最充分的保留子宫的盆腔器官脱垂 (POP) 手术）相对于经阴道全子宫切除术伴骶棘韧带固定 (TVH/SSLF)（一种常用的基于子宫切除术的手术）的比较效果。阴道子宫阴道脱垂手术。该概念提案的具体目标是：1) 比较接受 2-4 期 POP 子宫阴道脱垂手术的女性在术后 2 年后 SSH 与 TVH/SSLF 的解剖学、功能、性和健康相关的生活质量结果； 2) 比较这些相同女性的手术恢复情况以及 SSH 和 TVH/SSLF 的短期和长期发病率；3) 确定 SSH 与 TVH/SSLF 相比治疗 2-4 期 POP 的增量成本效益。纳入的受试者将在手术当天在手术室随机分配，使用随机排列区组设计接受 SSH 或 TVH/SSLF (1:1)。随机化将由外科医生分层，以考虑不同的经验和专业知识。在研究完成之前，受试者和研究协调员将对治疗分配不知情。相关性：近四分之一的女性报告至少有一种 PFD 症状，包括脱垂。 POP 是绝经后妇女子宫切除术最常见的适应症，目前尚不清楚在 POP 手术中加入子宫切除术是否是手术成功的必要条件。我们的概念提案的结果可以证明或消除美国每年多达 70,000 例子宫切除术的需要。