NCT02059954已完成不适用
Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial
Medical University of Graz6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Operating time (min.)
研究概览
简要总结
Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing.
This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
- •clinical exam indicates vaginal hysterectomy is feasible
- •no major concomitant surgery
- •able to complete questionnaires in German
排除标准
- •uterine malignancy
- •major concomitant surgery (e.g., for incontinence or prolapse)
- •clinical exam indicating vaginal hysterectomy not feasible
- •contraindication for surgery or laparoscopy
研究组 & 干预措施
Vaginal hysterectomy
Active Comparator
Vaginal hysterectomy
干预措施: Hysterectomy (Procedure)
Total laparoscopic hysterectomy
Active Comparator
Laparoscopic hysterectomy
干预措施: Hysterectomy (Procedure)
结局指标
主要结局
Operating time (min.)
时间窗: Surgery
Operating time (min.)
次要结局
- Complications(6 weeks)
- Anesthesia time (min.)(surgery)
- Quality of life(12 months)
- Sexual health(12 months)
- Return to work(3 months)
研究者
研究点 (6)
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