Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean finger ischemia time
研究概览
简要总结
Background: Raynaud's phenomenon is a vasospasm of the extremities, leading to extensive discomfort in daily life and potentially severe ischemia. Some patients are resistant to conventional vasodilatory drug treatment. In the University Medical Center Groningen, single-port thoracoscopic sympathicotomy (SPTS) was developed. This is a new minimally invasive endoscopic technique, extensively limiting surgical burden. In many hospitals in the Netherlands, this operation is sometimes performed on patients with Raynaud's phenomenon. However, the techniques used are more invasive than the SPTS technique. Furthermore, studies on sympathectomy and sympathicotomy in Raynaud's are limited and encompass obsolete more invasive techniques. Also, it is unclear which patients would benefit the most and for how long and in which percentage of patients treatment effects persist over time. In a recent study on the new SPTS technique, it was found that one month after the procedure, the Raynaud's attacks were substantially reduced and the hand perfusion increased on the operated side. Based on these short term effects and previously reported broad experience with this technique for other indications, it is possible to offer this option to a broader range of patients with Raynaud's as a reasonable and safe treatment option. However, whether the effects persist on the long-term needs to be established.
Main research question: The aim of the study is to assess the 5 year efficacy and outcome in patients with primary and secondary Raynaud's phenomenon in whom SPTS has been performed.
Design (including population, confounders/outcomes): Patients with Raynaud's, who will undergo SPTS in patient care setting, will be included. Data from the patient file will be collected, including vascular measurements to assess hand perfusion, a Raynaud diary (Raynaud condition score, duration and frequency of the attacks), quality of life questionnaires, and adverse events.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Raynaud's phenomenon of the hands
- •Scheduled SPTS as treatment for RP
- •Age ≥ 16 years
排除标准
- •SPTS for other indications than RP
结局指标
主要结局
Mean finger ischemia time
时间窗: 5 year
Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 5 years of follow-up, in minutes
次要结局
- Diastolic blood pressure(2 and 5 years)
- Raynaud Condition Score(1,2,3,4,5 years)
- Compensatory sweating(1,2,3,4,5 years)
- Number of attacks(1,2,3,4,5 years)
- Capillary density(2 and 5 years)
- Capillaroscopic pattern(2 and 5 year)
- Wound infection or other adverse events(2 weeks, 1,2,3,4,5 years)
- Mean finger ischemia time(2 year)
- SF-36(1,2,3,4,5 years)
- Number of dilated capillaries(2 and 5 year)
- Digital ulcers(1,2,3,4,5 years)
- Duration of attacks(1,2,3,4,5 years)
- Systolic blood pressure(2 and 5 years)
- Mean finger blood pressure(2 and 5 years)
- Pulse wave velocity brachial-ulnar(2 and 5 years)
- HAQ(1,2,3,4,5 years)
- Number of giant capillaries(2 and 5 year)
- Pulse wave velocity brachial-radial(2 and 5 years)
研究者
dr. DJ Mulder
Vascular internist, Principal investigator
University Medical Center Groningen