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.
Study Type
OBSERVATIONAL
Enrollment
50
Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure
University Medical Center Groningen
Groningen, Netherlands
RECRUITINGMean finger ischemia time
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
Time frame: 5 year
Mean finger ischemia time
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
Time frame: 2 year
Raynaud Condition Score
Mean Raynaud condition score (0-100) over a period 14 days
Time frame: 1,2,3,4,5 years
Number of attacks
Mean number of RP attacks per day over a period of 14 days
Time frame: 1,2,3,4,5 years
Duration of attacks
Mean duration of RP attacks per day over a period of 14 days in minutes
Time frame: 1,2,3,4,5 years
SF-36
Health-related quality of life short form (SF)-36 score of 100-0
Time frame: 1,2,3,4,5 years
HAQ
(Dutch) health assessment questionnaire (HAQ) score of 0-3
Time frame: 1,2,3,4,5 years
Capillary density
Mean number of capillaries per finger of 8 fingers per 3mm
Time frame: 2 and 5 years
Number of dilated capillaries
Mean number of dilated capillaries per finger (apex width \>20µm, \<50µm) of 8 fingers per 3mm
Time frame: 2 and 5 year
Number of giant capillaries
Mean number of giant capillaries per finger (apex width \>50µm) of 8 fingers per 3mm
Time frame: 2 and 5 year
Capillaroscopic pattern
Pattern of nailfold capillaries (normal, non-specific, early, active or late)
Time frame: 2 and 5 year
Pulse wave velocity brachial-radial
Pulse wave velocity in m/s of brachial-radial trajectory
Time frame: 2 and 5 years
Systolic blood pressure
Brachial systolic blood pressure in mmHg
Time frame: 2 and 5 years
Diastolic blood pressure
Brachial diastolic blood pressure in mmHg
Time frame: 2 and 5 years
Mean finger blood pressure
Mean finger blood pressure in mmHg of eight fingers
Time frame: 2 and 5 years
Pulse wave velocity brachial-ulnar
Pulse wave velocity in m/s of brachial-ulnar trajectory
Time frame: 2 and 5 years
Digital ulcers
Incidence of digital ulcers (yes/no)
Time frame: 1,2,3,4,5 years
Compensatory sweating
Compensatory sweating (yes/no)
Time frame: 1,2,3,4,5 years
Wound infection or other adverse events
Occurrence of wound infection or other adverse events potentially related to SPTS
Time frame: 2 weeks, 1,2,3,4,5 years
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