The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Proportion of women with suspected SPE undergoing diagnostic laparoscopy that were approached for the study an agreed to randomisation
研究概览
简要总结
Endometriosis is a chronic, incurable condition that affects about 10% of women of reproductive age. It is defined as a growth of cells similar to the womb lining outside of the womb in the pelvis, and is associated with chronic pelvic pain, excessive period pain, pain with sexual intercourse and difficulties in getting pregnant. If the disease is found only on the lining of the pelvis it is known as "superficial peritoneal" and is usually treated during a laparoscopic surgery by cutting out (excision) or burning off (ablation). However, many women do not find improvement in their symptoms after the surgery and can have complications from the procedure. The aim of this study is to determine if removal of the superficial peritoneal endometriosis improves pain symptoms and quality of life, which method of removal (excision or ablation) is more effective or if surgical removal is of no benefit to the patients and can potentially cause harm. The investigators plan to recruit up to 90 women from four NHS hospitals in Scotland over a period of 12 months. Women who are attending gynaecology departments with pelvic pain who have not previously had a diagnosis of endometriosis via laparoscopy will be approached. Patients will be asked to read an information sheet about the trial. Women who consent to the trial will be randomised during the surgery, if superficial endometriosis is found, to either having the endometriosis removed or not. For this pilot, follow up will be at 3 and 6 months (and obtain permission to continue to follow them up at 12 and 24 months should time and finding permit). Patients who do not consent to take part in the trial will be asked if the investigators can collect data on their demographics and reasons on why they did not wish to take part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
General Practitioner
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing laparoscopy for the investigation of chronic pelvic pain
- •In order to be randomised, isolated superficial peritoneal endometriosis (SPE) must be identified at laparoscopy (macroscopically)
- •Able to give informed consent
排除标准
- •Previous surgical diagnosis of endometriosis
- •Pregnant or are actively trying for pregnancy within the next six months
- •Deep endometriosis or ovarian endometrioma on imaging or at laparoscopy
- •Peritoneal 'pockets' only noted at laparoscopy
结局指标
主要结局
Proportion of women with suspected SPE undergoing diagnostic laparoscopy that were approached for the study an agreed to randomisation
时间窗: Screening
The proportion of screened women who are eligible for the trial determined from the screening logs
次要结局
- Baseline characteristics of eligible women that agree to be randomised and those that decline participation(Screening)
- Proportion of women having laparoscopy for investigation of chronic pelvic pain that are eligible (i.e. have only SPE) for the trial(visit 2 (day of surgery))
- Effects of treatment and variability in treatment outcomes(Throughout the trial starting from day of surgery until end of followup at 6 months)
- To determine the most acceptable methods of assessment tools(Throughout the trial until end of follow up at 6 months)
- To determine the most acceptable methods of recruitment, randomisation and assessment tools(6 months follow up)
- To determine the most acceptable methods of recruitment and assessment tools(Questionnaires collected at Baseline (within a week of surgery), 3 and 6 months follow up)
- Improvement in quality of life(day of surgery, follow up at 3 and 6 months)