Clinical trial NCT04015193: Follow-up of SPTS in Patients With Raynaud's Phenomenon
Official title: Follow-up of Single-port Thoracoscopic Sympathicotomy in Patients With Raynaud's Phenomenon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Raynaud Phenomenon
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Raynaud's phenomenon

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.


Eligibility criteria: Inclusion Criteria:

* Raynaud's phenomenon of the hands
* Scheduled SPTS as treatment for RP
* Age ≥ 16 years

Exclusion Criteria:

• SPTS for other indications than RP

Primary outcomes:
measure: Mean finger ischemia time
timeFrame: 5 year
Secondary outcomes:
measure: Mean finger ischemia time
timeFrame: 2 year
measure: Raynaud Condition Score
timeFrame: 1,2,3,4,5 years
measure: Number of attacks
timeFrame: 1,2,3,4,5 years
measure: Duration of attacks
timeFrame: 1,2,3,4,5 years
measure: SF-36
timeFrame: 1,2,3,4,5 years
measure: HAQ
timeFrame: 1,2,3,4,5 years
measure: Capillary density
timeFrame: 2 and 5 years
measure: Number of dilated capillaries
timeFrame: 2 and 5 year
measure: Number of giant capillaries
timeFrame: 2 and 5 year
measure: Capillaroscopic pattern
timeFrame: 2 and 5 year
measure: Pulse wave velocity brachial-radial
timeFrame: 2 and 5 years
measure: Systolic blood pressure
timeFrame: 2 and 5 years
measure: Diastolic blood pressure
timeFrame: 2 and 5 years
measure: Mean finger blood pressure
timeFrame: 2 and 5 years
measure: Pulse wave velocity brachial-ulnar
timeFrame: 2 and 5 years
measure: Digital ulcers
timeFrame: 1,2,3,4,5 years
measure: Compensatory sweating
timeFrame: 1,2,3,4,5 years
measure: Wound infection or other adverse events
timeFrame: 2 weeks, 1,2,3,4,5 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University of Groninge, University Medical Center Groningen
name: Douwe J Mulder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: