Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Postsurgical change in bleeding patterns dependent on cavum probe length.
研究概览
简要总结
CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CavatermTM operation because of menorrhagia
- •timeframe: January 2006 till August 2009
- •older than 29 years and younger than 56 years
排除标准
- •pregnancy
- •fragmentary filled questionnaire
- •more than 1 CavatermTM operation
结局指标
主要结局
Postsurgical change in bleeding patterns dependent on cavum probe length.
时间窗: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.
Postsurgical change in patient satisfaction dependent on cavum probe length.
时间窗: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
The questionnaire will ask for satisfaction and recommendation to the best friend.
次要结局
- Postsurgical change in dyspareunia(A questionnaire will be sent in September 2010, at least after one postsurgical year.)
- Postsurgical change in Premenstrual Syndrome(A questionnaire will be sent in September 2010, at least after one postsurgical year.)
- Prevention of further gynaecological therapies(A questionnaire will be sent in September 2010, at least after one postsurgical year.)
- Improvement of quality of life(A questionnaire will be sent in September 2010, at least after one postsurgical year.)
研究者
Beda Hartmann
Univ.-Doz. Dr. Mag.
Medical University of Vienna