Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
研究概览
简要总结
To determine the quality of life following the radical excision of recto-vaginal endometriosis.
详细描述
Patients undergoing surgery for severe endometriosis with bowel involvement were asked to complete pre-operative and post operative questionnaires at 2, 6 and 12 months, then 5, 10, 15, 20 and 25 years post operatively.
Quality of life measured using the EHP-30 and EQ-5D questionnaires. Bowel symptoms were measured using GIQLI. Dysmenorrhoea, dyspareunia, dyschezia and chronic pain were measured using a visual analogue scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women undergoing planned surgery for severe endometriosis with bowel involvement.
排除标准
- •Patients who declined to complete questionnaires for whatever reason and/or have their anonymous data analysed.
结局指标
主要结局
Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
时间窗: 1 year post operative
Recruitment is continuous
Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.
时间窗: 1 year post operative
Recruitment is continuous
Chronic pain measured using a visual analogue scale (VAS).
时间窗: 1 year post operative
Recruitment is continuous
Dyspareunia measured using a visual analogue scale (VAS).
时间窗: 1 year post operative
Recruitment is continuous
Dyschezia measured using a visual analogue scale (VAS).
时间窗: 1 year post operative
Recruitment is continuous
Dysmenorrhoea measured using a visual analogue scale (VAS).
时间窗: 1 year post operative
Recruitment is continuous
次要结局
- Dysmenorrhoea measured using a visual analogue scale.(2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative)
- Bowel symptoms were measured using GIQLI.(2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative)
- Dyschezia measured using a visual analogue scale.(2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative)
- Quality of life measured using the EHP-30 and EQ-5D questionnaires.(2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative)
- Dyspareunia measured using a visual analogue scale.(2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative)
- Chronic pain measured using a visual analogue scale.(2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative)
研究者
Mr Andrew Kent
Consultant Gynaecologist
Royal Surrey County Hospital NHS Foundation Trust