Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.
详细描述
The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing hysterectomy for benign indications within 8 weeks of enrollment
- •Women >18 years of age
- •Non-emergent surgery
- •Non-pregnant
排除标准
- •Candidate for vaginal hysterectomy
- •Uterine size >14 weeks by clinical exam OR >300 mL by ultrasound measurement
- •History of cancer of reproductive tract
- •Requires concomitant pelvic organ prolapse (POP) surgery
- •Requires surgery for urinary incontinence
- •Has acute angle glaucoma
- •Has severe cardiac/respiratory disease
- •Desires supracervical hysterectomy
研究组 & 干预措施
Laparoscopic hysterectomy
Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
干预措施: Laparoscopic hysterectomy (Procedure)
Abdominal hysterectomy
Total Abdominal Hysterectomy
干预措施: Abdominal hysterectomy (Procedure)
结局指标
主要结局
Quality of life
时间窗: 1 year
1) Patient-centered outcomes composite 1. Quality of life - measured using the Short Form 12 (SF-12v2), 2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ) 3. Body image - measured using the Body Image Scale (BIS) 4. Return to normal activity -measured using the Activities Assessment Scale (AAS) 5. Pain - measured using a 10 point likert scale 6. Productivity - measured using a questionnaire about missed work
次要结局
- Cost(1 year)
- Complications(1 year)
研究者
Kinberly Kho
Associate Professor, Department of Obstetrics and Gynecology
University of Texas Southwestern Medical Center