Excessive Sweating of the Hands Clinical Trial
Official title:
The Effect of Adding Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3 Versus Thoracoscopic Sympathectomy in Palmar Hyperhidrosis.
Primary hyperhidrosis is a disorder characterized by excessive and chronic sweating in the
absence of a sweating trigger. The disorder can be severe and interfere with normal daily
activities of the patients.
The gold-standard treatment in severe cases of hyperhidrosis is thoracoscopic sympathectomy
betweenT2 and T4. These procedures are regularly performed in surgical units under general
anaesthesia which needs special anesthetic considerations which is complex and associated
with a lot of complications.
Radiofrequency ablation of the sympathetic chain for treatment of hyperhidrosis is considered
alternative to thoracoscopic sympathectomy. The procedure is safe, inexpensive and done under
sedation with local anaesthesia in an outpatient setting, but its success rate is still
significantly lower than endoscopic sympathectomy.
The purpose of this study is to determine whether adding phenol 6% in a mixture with glycerin
will increase the efficacy of fluoroscopy guided radiofrequency ablation of T2, T3
sympathetic ganglia in hyperhidrosis in comparison to surgery without significant side
effects to provide safe and effective method rather than surgery.
Primary hyperhidrosis is a disorder characterized by excessive, chronic sweating in the
absence of a sweating trigger. This condition must be differentiated from secondary
hyperhidrosis, which is due to a lot of stimuli as infection, malignancy, drugs, anxiety,
neurological and endocrine disorders.
Primary hyperhidrosis is caused by hyperactivity of the sympathetic system. The etiology of
the disease is unknown and appears simultaneously. It affects patients between 15 and 40
years of age and may cause serious damage to their quality of life.
The first line of treatment of hyperhidrosis is non-surgical methods as topical
antiperspirants, anti-cholinergic and Botox, but the disadvantages of this treatment are
short term relieve, so repetition of this treatment is required.
Thoracoscopic Sympathectomy of the sympathetic chain between T2 and T4 is considered the
gold-standard treatment in severe cases of hyperhidrosis. These procedures are performed in
surgical units under general anaesthesia which needs special anesthetic considerations in the
form of double lumen tube and one lung ventilation.
Complications like pneumothorax, surgical emphysema, lung injury, lobar collapse,
atelectasis, pleural effusion; bleeding, Horner's syndrome and neuritis have been described.
Postoperative pain is more severe which can occasionally require opiate analgesia.
Radiofrequency ablation of the sympathetic chain is considered alternative to thoracoscopic
sympathectomy for hyperhidrosis. The procedure is safe, inexpensive and done under sedation
with local anaesthesia in an outpatient setting, but its success rate is still significantly
lower than endoscopic sympathectomy.
McCormack et al. concluded that there are anatomical variations in the position of
sympathetic trunk which are thought to be one of the main causes of failure and patient
dissatisfaction after thoracic sympathetic neurolysis in hyperhidrosis.
Previous studies tried to increase the efficacy of radiofrequency ablation of T2, T3
sympathetic ganglia in hyperhidrosis via adding alcohol 100% to cover the anatomical
variations of the sympathetic trunk. Alcohol is intensely painful during injection, so large
volume of local anaesthetics is injected prior to alcohol. Also, it is hypobaric, water
soluble and spread rapidly from the injection site, so large volume is required. In addition,
the incidence of neuritis is very high with its injection.
Phenol is primarily a local anesthetic at lower concentrations and becomes more neurolytic at
higher concentration. Unlike alcohol, it is not painful on injection. It is prepared in a
mixture with glycerin so it is highly soluble and hyperbaric and diffuses slowly into the
local tissues.
In this study, the effect of adding phenol 6% with percutaneous fluoroscopy guided
radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis will be evaluated. The
study hypothesizes that adding phenol 6% in a mixture with glycerin will increase the
efficacy of radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis in
comparison to surgery without significant side effects to provide safe and effective method
rather than surgery for hyperhidrosis.
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