Follow-up of SPTS in Patients With Raynaud's Phenomenon
- Conditions
- Raynaud Phenomenon
- Interventions
- Procedure: Single-port thoracoscopic sympathicotomy (patient care)
- Registration Number
- NCT04015193
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Raynaud's phenomenon of the hands
- Scheduled SPTS as treatment for RP
- Age ≥ 16 years
• SPTS for other indications than RP
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-responders Single-port thoracoscopic sympathicotomy (patient care) Non-responders: no or less than 25% reduction in Raynaud condition score and/or finger ischemia time during cooling and recovery. Full responders Single-port thoracoscopic sympathicotomy (patient care) Full responders: no signs or symptoms of Raynaud's phenomenon (RP) in Raynaud condition score, no RP during cooling-recovery experiment. Partial responders Single-port thoracoscopic sympathicotomy (patient care) Partial responders: at least 25% reduction in Raynaud condition score and finger ischemia time during cooling and recovery.
- Primary Outcome Measures
Name Time Method Mean finger ischemia time 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
- Secondary Outcome Measures
Name Time Method Number of dilated capillaries 2 and 5 year Mean number of dilated capillaries per finger (apex width \>20µm, \<50µm) of 8 fingers per 3mm
Digital ulcers 1,2,3,4,5 years Incidence of digital ulcers (yes/no)
Systolic blood pressure 2 and 5 years Brachial systolic blood pressure in mmHg
Pulse wave velocity brachial-radial 2 and 5 years Pulse wave velocity in m/s of brachial-radial trajectory
Diastolic blood pressure 2 and 5 years Brachial diastolic blood pressure in mmHg
SF-36 1,2,3,4,5 years Health-related quality of life short form (SF)-36 score of 100-0
Compensatory sweating 1,2,3,4,5 years Compensatory sweating (yes/no)
Number of attacks 1,2,3,4,5 years Mean number of RP attacks per day over a period of 14 days
Raynaud Condition Score 1,2,3,4,5 years Mean Raynaud condition score (0-100) over a period 14 days
Capillary density 2 and 5 years Mean number of capillaries per finger of 8 fingers per 3mm
Capillaroscopic pattern 2 and 5 year Pattern of nailfold capillaries (normal, non-specific, early, active or late)
Mean finger ischemia time 2 year Mean finger ischemia time of five fingers during cooling and recovery, as assessed by routine cooling and recovery photo-electric plethysmography (PPG) after 2 years of follow-up, in minutes
Duration of attacks 1,2,3,4,5 years Mean duration of RP attacks per day over a period of 14 days in minutes
Mean finger blood pressure 2 and 5 years Mean finger blood pressure in mmHg of eight fingers
Pulse wave velocity brachial-ulnar 2 and 5 years Pulse wave velocity in m/s of brachial-ulnar trajectory
HAQ 1,2,3,4,5 years (Dutch) health assessment questionnaire (HAQ) score of 0-3
Number of giant capillaries 2 and 5 year Mean number of giant capillaries per finger (apex width \>50µm) of 8 fingers per 3mm
Wound infection or other adverse events 2 weeks, 1,2,3,4,5 years Occurrence of wound infection or other adverse events potentially related to SPTS
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands