Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Primary Palmar Hyperhidrosis
Primary Purpose
Primary Palmar Hyperhydrosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic thoracic T3 sympathectomy
ThoracicT3 radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Primary Palmar Hyperhydrosis
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.
Sites / Locations
- Ain shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endoscopic thoracic T3 sympathectomy
ThoracicT3 radiofrequency ablation
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
compensatory sweating
detected by sweating of chest, abdomen, back, head and neck
compensatory sweating
detected by sweating of chest, abdomen, back, head and neck
number of patients develope pneumothorax
detected by chest x ray
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.
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.
Full Information
NCT ID
NCT05737914
First Posted
February 10, 2023
Last Updated
February 17, 2023
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05737914
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Palmar Hyperhydrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic thoracic T3 sympathectomy
Arm Type
Active Comparator
Arm Title
ThoracicT3 radiofrequency ablation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic thoracic T3 sympathectomy
Intervention Description
Interruption of intrathoracic sympathetic neural pathway surgically to treat hyperhidrosis by using video - thoracoscopy
Intervention Type
Procedure
Intervention Name(s)
ThoracicT3 radiofrequency ablation
Intervention Description
radiofrequency ablation at third thoracic spine it may be a good option for treatment of primary hyperhidrosis.
Primary Outcome Measure Information:
Title
success rate
Description
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.
Time Frame
one week after surgery
Title
success rate
Description
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.
Time Frame
one month after surgery
Secondary Outcome Measure Information:
Title
compensatory sweating
Description
detected by sweating of chest, abdomen, back, head and neck
Time Frame
one week after surgery
Title
compensatory sweating
Description
detected by sweating of chest, abdomen, back, head and neck
Time Frame
one month after surgery
Title
number of patients develope pneumothorax
Description
detected by chest x ray
Time Frame
immediately after surgery
Title
recurrence of sweating
Description
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.
Time Frame
one week after surgery
Title
recurrence of sweating
Description
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.
Time Frame
one month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramy m, MD
Phone
01281431097
Email
ramy.ahmed@med.asu.edu.eg
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
20
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Primary Palmar Hyperhidrosis
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