Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Primary Palmar Hyperhidrosis

Study Overview
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Brief Summary
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Primary hyperhidrosis disease is characterized by much more sweating above the needs for thermoregulation, which is worsen by increased temperature and emotional factors it can be seen in the palms of the hands, soles of the feet/ face and so on. Hyperhidrosis usually starts since childhood and continuous throughout life aggravated by emotional stress or by high environmental temperature. Many lines of treatment were tried such as anticholinergic drug, physiotherapy. Endoscope thoracic sympathectomy and radio frequency with phenol injection.

Detailed Description
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Interruption of intrathoracic sympathetic neural pathway surgically to treat hyperhidrosis by using video - thoracoscopy which has lead to explosion of minimally invasive technique for this issue. It's safe procedure and success rate in about 95% so it's result in this disease are rewarding. Other technique will be studied in this current study is radiofrequency ablation it may be a good option for treatment of primary hyperhidrosis. When endoscope is not allowed. An early outcome is our primary target for comparing the two different techniques. Treatment with radiofrequency can benefit patients specially young one because a lot of them refuse endoscopic sympathectomy with its special anesthetic consideration as one lung ventilation and sometimes patient left with intercostal tube for some days so it's considered difficult procedure and much more easy is radiofrequency but alone the results is not satisfactory so in this clinical trial endoscopic sympathectomy will be compared with radiofrequency ablation regarding to the early outcome for the two procedure in this clinical trial interruption of sympathetic chain was chosen at the level of T3 because at this level interruption involve only the sympathetic chain without any ganglion damage or compensatory sweating which was seen when the interruption of the level of T4.

Official Title
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Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Treatment of Primary Palmar Hyperhidrosis

Conditions
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Primary Palmar Hyperhydrosis

Intervention / Treatment
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* Procedure: Endoscopic thoracic T3 sympathectomy
* Procedure: ThoracicT3 radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary palmar hyperhydrosis. Patients with American society classification 1 and 2. Exclusion Criteria: Patient refusal. Previous sympathectomy either endoscopic or by radiofrequency. Previous sternotomy operation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic thoracic T3 sympathectomy<br> | Procedure: Endoscopic thoracic T3 sympathectomy<br>* Interruption of intrathoracic sympathetic neural pathway surgically to treat hyperhidrosis by using video - thoracoscopy<br>|
| Active Comparator: ThoracicT3 radiofrequency ablation<br> | Procedure: ThoracicT3 radiofrequency ablation<br>* radiofrequency ablation at third thoracic spine it may be a good option for treatment of primary hyperhidrosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | measured by the hyperhidrosis disease severity score. A score of 1 or 2 was classified as mild or moderate hyperhidrosis and a score of 3 or 4 was classified as severe hyperhidrosis. | one week after surgery | 
| success rate | measured by the hyperhidrosis disease severity score. A score of 1 or 2 was classified as mild or moderate hyperhidrosis and a score of 3 or 4 was classified as severe hyperhidrosis. | one month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compensatory sweating | detected by sweating of chest, abdomen, back, head and neck | one week after surgery | 
| compensatory sweating | detected by sweating of chest, abdomen, back, head and neck | one month after surgery | 
| number of patients develope pneumothorax | detected by chest x ray | immediately after surgery | 
| recurrence of sweating | measured by the hyperhidrosis disease severity score. A score of 1 or 2 was classified as mild or moderate hyperhidrosis and a score of 3 or 4 was classified as severe hyperhidrosis. | one week after surgery | 
| recurrence of sweating | measured by the hyperhidrosis disease severity score. A score of 1 or 2 was classified as mild or moderate hyperhidrosis and a score of 3 or 4 was classified as severe hyperhidrosis. | one month after surgery |