Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Primary Palmar Hyperhidrosis
- Conditions
- Primary Palmar Hyperhydrosis
- Interventions
- Procedure: Endoscopic thoracic T3 sympathectomyProcedure: ThoracicT3 radiofrequency ablation
- Registration Number
- NCT05737914
- Lead Sponsor
- Ain Shams University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 68
- Patients with primary palmar hyperhydrosis.
- Patients with American society classification 1 and 2.
- Patient refusal.
- Previous sympathectomy either endoscopic or by radiofrequency.
- Previous sternotomy operation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endoscopic thoracic T3 sympathectomy Endoscopic thoracic T3 sympathectomy - ThoracicT3 radiofrequency ablation ThoracicT3 radiofrequency ablation -
- Primary Outcome Measures
Name Time Method success rate one month after surgery 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.
- Secondary Outcome Measures
Name Time Method recurrence of sweating one month after surgery 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.
compensatory sweating one month after surgery detected by sweating of chest, abdomen, back, head and neck
number of patients develope pneumothorax immediately after surgery detected by chest x ray
Trial Locations
- Locations (1)
Ain shams university
🇪🇬Cairo, Egypt