NCT02282943已完成不适用
Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
Mr Andrew Kent0 个研究点目标入组 112 人开始时间: 2002年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 主要终点
- Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
研究概览
简要总结
The purpose of this study is to compare laser CO2 ablation/excision of Endometriosis (AFS stages 1-3) with excision of endometriosis using the Ethicon Harmonic ACE device. Pain scores at 6 months was the primary outcome, but secondary outcomes assessed pain scores at 1, 3 and 5 years as well as psychological state and quality of life.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Endometriosis grade I-III by revised American Fertility Society Scoring
- •Patients in whom laser treatment to the endometriosis is considered the treatment of choice.
- •Patients having consented to participated in the trial
- •Patient is 18 years old or greater
- •Patients who have no contraindications to either of the treatment modalities proposed
排除标准
- •Patients who do not wish to participate/have not signed the informed consent form
- •Pregnancy of breast feeding
- •Patients who are unable or unwilling to discontinue hormonal treatment for 6 months
- •Patients who have received additional treatment for their endometriosis within 6 months of surgery
- •Patients with documented painful conditions of the gastrointestinal or urinary system
结局指标
主要结局
Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
时间窗: 6 months
次要结局
- Quality of life survey (Endometriosis Health Profile Questionnaire)(0, 3, 6 months and 1,3,5 years)
- Visual analogue pain score (VAS) change from baseline(1,3 and 5 years)
- Psychological state(0, 3 ,6 months and 1,3,5 years)
研究者
Mr Andrew Kent
Consultant Gynaecologist
Royal Surrey County Hospital NHS Foundation Trust
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