Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 302
- 试验地点
- 17
- 主要终点
- cost-utility ratio, according to the societal perspective of the of the management of Bartholin's gland abscess by the Word catheter compared to the incision-drainage
研究概览
简要总结
Bartholin's gland abscess is a condition requiring emergency consultation. Placement of a Word catheter, which is a minor technique used in France as a treatment of bartholin's Abscess, can be done in an emergency room without hospitalization. Actually, incision-drainage, which is the most widespread treatment in France, is performed on day surgery with or without overnight hospitalization. Our hypothesis is that the use of Word catheter compared to incision-drainage would not modify the quality of life of the patients but would allow a saving of up to 3 M€ per year in France.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Abscess of Bartholin's gland Patient able to understand the protocol Patient who signed informed consent Patient with social insurance
排除标准
- •Spontaneous fistulization of the abscess before surgical treatment Abscess volume under 3 ml Medical treatment which avoid incision or word catheter placement patients under guardianship Unable to complete questionnaires Patients not affiliated to social protection regimen Pregnant or post-partum women (until 4 weeks after delivery)
结局指标
主要结局
cost-utility ratio, according to the societal perspective of the of the management of Bartholin's gland abscess by the Word catheter compared to the incision-drainage
时间窗: 12 months
The utility will be measured by: Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible. The costs will be measured by the addition of the following costs: Outpatient resource consumption collected in a declarative patient questionnaire. Hospital care resources using the the database of the Medicalised Information System Program of each recruiting site
次要结局
- Comparison of Word catheter versus incision-drainage in terms of complications(12 months)
- Non inferiority evaluation of Word catheter versus incision-drainage in terms of recurrence rate(12 months)
- Comparison of Word catheter versus incision-drainage concerning pain(12 months)
- Comparison of Word catheter versus incision-drainage concerning management time(Day 0 (procedure day), Day 1)
- Comparison of Word catheter versus incision-drainage in terms of surgical failure(Immediate post-operative (D0) and one month)
- Comparison of Word catheter versus incision-drainage in terms of impact on sexual activity(Baseline, one month, 6 months and 12 months)
- Comparison of Word catheter versus incision-drainage in terms global patient impression and improvement(One day, one month, 3 months, 6 months, 9 months and 12 months)
- Budget impact analysis for the health insurance point of view in case of diffusion of the Word catheter(5 years)
- Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain(at baseline and day 1)
- Comparison of Word catheter versus incision-drainage in terms of quality of life using the EQ-5D(Baseline, one day, one month, 3 months, 6 months, 9 months and 12 months)
- Comparison of Word catheter versus incision-drainage in terms of quality of life using the SF-12-HS(Baseline, one month, 6 months and 12 months)