Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery: A Pilot Trial (ICE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of eligible women
研究概览
简要总结
Endometriosis is a common (around 1 in 10 women), non-cancerous condition where tissue similar to the womb lining is found growing elsewhere, most commonly inside the pelvis. Symptoms vary but can include intense pelvic pain and infertility.
Endometriosis that is very deep and painful may need surgery, which risks damage to the tubes that drain urine from the kidneys to the bladder (ureters). To reduce this risk, surgeons may put tiny plastic tubes called "stents" inside the ureters. These stents can stay for up-to 4 weeks following surgery but can cause severe pain and blood in the urine. Squirting a dye into the ureters, rather than using stents, may cause less pain for women after surgery whilst not making the removal of endometriosis worse, the operation take longer, or increasing the rates of complications (such as bleeding or damage to internal organs). Before a full clinical study can be run, the investigators need to understand whether this is possible, by doing a feasibility study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 50 years
- •Scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis (DE) where ureteric stenting is planned.
- •Willing and able to provide consent for participation in the study
排除标准
- •Confirmed or suspected pregnancy at the time of enrolment.
- •Suspicion or confirmation of malignancy.
- •History of ureteric injury from prior surgery or trauma
- •Medically unfit for surgery due to the following conditions:
- •Uncontrolled diabetes mellitus.
- •Severe Chronic Obstructive Pulmonary Disease (COPD).
- •Hypertrophic cardiomyopathy or significant cardiac conditions (e.g., recent myocardial infarction, aortic stenosis).
- •History of stroke or severe kyphoscoliosis.
- •Uncontrolled hypertension.
- •Body mass index (BMI): BMI greater than 45
结局指标
主要结局
Number of eligible women
时间窗: 24 months
The number of eligible women across 2 UK sites that are suitable for trial recruitment
Attrition rate in follow up process
时间窗: 24 months
Recording the percentage of people who drop out before the completion
Missing data in follow up process
时间窗: 24 months
Recording how much data is missing from the follow up data
Proportion of eligible women agreeing to participate
时间窗: 24 months
Number of women who are eligible that then take part in the trial
Acceptability of the trial interventions and follow-up processes
时间窗: 24 months
Recording how acceptable participants find the trial interventions and follow up process. This will be done using a focus group
Reasons for declining participation or withdrawal after agreeing to participate
时间窗: 24 months
Recording the list of reasons people withdraw from the study or decline to take part
次要结局
未报告次要终点