Clinical trial NCT05737914: Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Primary Palmar Hyperhidrosis
Official title: Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Treatment of Primary Palmar Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Palmar Hyperhydrosis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: success rate
timeFrame: one week after surgery
measure: success rate
timeFrame: one month after surgery
Secondary outcomes:
measure: compensatory sweating
timeFrame: one week after surgery
measure: compensatory sweating
timeFrame: one month after surgery
measure: number of patients develope pneumothorax
timeFrame: immediately after surgery
measure: recurrence of sweating
timeFrame: one week after surgery
measure: recurrence of sweating
timeFrame: one month after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References: