University Medical Centre Groningen
Groningen, Netherlands
NCT Number: NCT02680509
The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Groningen, Netherlands
Raynaud's phenomenon is discoloration, discomfort and numbness or pain in the fingers and toes as a result of excessively reduced blood flow due to sympathetic induced vasospasms, in response to a change in temperature or emotional stress. It usually affects multiple fingers of both hands and comes in frequent attacks, with little or no discomfort in between them. Current treatment consists of stepped-care, including preventive measures optimizing digital blood flow, oral and intravenous medical therapy aimed at improving microvascular circulation, surgical neuromodulation to achieve vasodilatation and neurostimulation.
While surgical sympathectomy is an established treatment of Raynaud's phenomenon, its more invasive nature has prevented widespread application as an initial therapy. After introduction of minimally invasive surgical techniques in recent years, the investigators have further optimized the endoscopic sympathicotomy procedure performed on hyperhidrosis patients, now needing only a single 1 cm port for a detailed, panoramic view of the sympathetic chain (1). This minimal invasive technique has proven to be a safe, efficient and reproducible treatment for several indications and seems also suitable for Raynaud's patients.
In this feasibility study, the researchers want to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
sympathicotomy R3 consists of transecting the sympathetic chain at the third costal level, cranial of the ganglia, leaving the ganglia themselves untouched
Time frame: 1 month follow up
Change from baseline in microvascular circulation at 1 month
Time frame: 6 month follow up
Change from baseline in microvascular circulation at 6 months
Time frame: 1, 6 and 12 months of follow-up
Change from baseline in quality of life as measured by Short Form 36 (SF36) at 1, 6 and 12 months
Michiel Kuijpers
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07112183
Cardiovascular Diseases, Connective Tissue Diseases
Boston, Massachusetts, United States
View Trial Details