Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737914
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-21
First Post:
2023-02-10
Brief Title:
Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Primary Palmar Hyperhidrosis
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Treatment of Primary Palmar Hyperhidrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Its safe procedure and success rate in about 95 so its 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 its 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
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 its 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None