Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3in Palmar Hyperhidrosis.
Primary Purpose
Excessive Sweating of the Hands
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Surgical sympathectomy
Radiofrequency ablation with phenol injection
Sponsored by
About this trial
This is an interventional treatment trial for Excessive Sweating of the Hands
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status grades I and II
Exclusion Criteria:
- Patient refusal.
- Hepatic impairement.
- Renal impairment.
- Neuromuscular diseases.
- History of opioid abuse.
- Coagulopathies.
- Cardiovascular diseases.
- Respiratory diseases.
- Previously failed cases either after percutaneous or thoracoscopic sympathectomy.
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgical sympathectomy
Radiofrequency ablation with phenol injection
Arm Description
All patients in this group will have standard surgical procedure
patient will receive radiofrequency ablation of T2 and T3 sympathetic ganglia + phenol 6% (0.5ml) injection
Outcomes
Primary Outcome Measures
Temperature of the ipsilateral palm of the hand
Secondary Outcome Measures
Postoperative pain scores
The level of pain based on visual analog scale (VAS) (where 0= no pain and 10= worst pain) will be assessed
postoperative cumulative analgesic consumption
Total amount of post-operative analgesics (ketorolac and fentanyl) will be recorded.
Occurrence of pneumothorax
Patients will be transferred to the PACU and chest x ray will be done to exclude pneumothorax.
Severity of compensatory hyperhidrosis
Compensatory hyperhidrosis defined as excessive sweating after the procedures in areas of the body that previously did not sweat mainly in axilla, back, and lower limbs and will be assessed and classified into 4 degrees Not present, Mild Sometimes noticeably sweaty and sometimes not sweaty, Moderate Always aware but not troublesome, or troublesome but controlled by clothing, and Sever Causes embarrassment
Patient satisfaction
Patient satisfaction with their procedure will be measured with a four-grade scale: 0 (not satisfied), 1 (slightly satisfied), 2 (satisfied) and 3 (very satisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03506828
Brief Title
Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3in Palmar Hyperhidrosis.
Official Title
The Effect of Adding Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3 Versus Thoracoscopic Sympathectomy in Palmar Hyperhidrosis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
January 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary hyperhidrosis is a disorder characterized by excessive and chronic sweating in the absence of a sweating trigger. The disorder can be severe and interfere with normal daily activities of the patients.
The gold-standard treatment in severe cases of hyperhidrosis is thoracoscopic sympathectomy betweenT2 and T4. These procedures are regularly performed in surgical units under general anaesthesia which needs special anesthetic considerations which is complex and associated with a lot of complications.
Radiofrequency ablation of the sympathetic chain for treatment of hyperhidrosis is considered alternative to thoracoscopic sympathectomy. The procedure is safe, inexpensive and done under sedation with local anaesthesia in an outpatient setting, but its success rate is still significantly lower than endoscopic sympathectomy.
The purpose of this study is to determine whether adding phenol 6% in a mixture with glycerin will increase the efficacy of fluoroscopy guided radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis in comparison to surgery without significant side effects to provide safe and effective method rather than surgery.
Detailed Description
Primary hyperhidrosis is a disorder characterized by excessive, chronic sweating in the absence of a sweating trigger. This condition must be differentiated from secondary hyperhidrosis, which is due to a lot of stimuli as infection, malignancy, drugs, anxiety, neurological and endocrine disorders.
Primary hyperhidrosis is caused by hyperactivity of the sympathetic system. The etiology of the disease is unknown and appears simultaneously. It affects patients between 15 and 40 years of age and may cause serious damage to their quality of life.
The first line of treatment of hyperhidrosis is non-surgical methods as topical antiperspirants, anti-cholinergic and Botox, but the disadvantages of this treatment are short term relieve, so repetition of this treatment is required.
Thoracoscopic Sympathectomy of the sympathetic chain between T2 and T4 is considered the gold-standard treatment in severe cases of hyperhidrosis. These procedures are performed in surgical units under general anaesthesia which needs special anesthetic considerations in the form of double lumen tube and one lung ventilation.
Complications like pneumothorax, surgical emphysema, lung injury, lobar collapse, atelectasis, pleural effusion; bleeding, Horner's syndrome and neuritis have been described. Postoperative pain is more severe which can occasionally require opiate analgesia.
Radiofrequency ablation of the sympathetic chain is considered alternative to thoracoscopic sympathectomy for hyperhidrosis. The procedure is safe, inexpensive and done under sedation with local anaesthesia in an outpatient setting, but its success rate is still significantly lower than endoscopic sympathectomy.
McCormack et al. concluded that there are anatomical variations in the position of sympathetic trunk which are thought to be one of the main causes of failure and patient dissatisfaction after thoracic sympathetic neurolysis in hyperhidrosis.
Previous studies tried to increase the efficacy of radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis via adding alcohol 100% to cover the anatomical variations of the sympathetic trunk. Alcohol is intensely painful during injection, so large volume of local anaesthetics is injected prior to alcohol. Also, it is hypobaric, water soluble and spread rapidly from the injection site, so large volume is required. In addition, the incidence of neuritis is very high with its injection.
Phenol is primarily a local anesthetic at lower concentrations and becomes more neurolytic at higher concentration. Unlike alcohol, it is not painful on injection. It is prepared in a mixture with glycerin so it is highly soluble and hyperbaric and diffuses slowly into the local tissues.
In this study, the effect of adding phenol 6% with percutaneous fluoroscopy guided radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis will be evaluated. The study hypothesizes that adding phenol 6% in a mixture with glycerin will increase the efficacy of radiofrequency ablation of T2, T3 sympathetic ganglia in hyperhidrosis in comparison to surgery without significant side effects to provide safe and effective method rather than surgery for hyperhidrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Sweating of the Hands
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Single blind (Investigator) study
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical sympathectomy
Arm Type
Active Comparator
Arm Description
All patients in this group will have standard surgical procedure
Arm Title
Radiofrequency ablation with phenol injection
Arm Type
Active Comparator
Arm Description
patient will receive radiofrequency ablation of T2 and T3 sympathetic ganglia + phenol 6% (0.5ml) injection
Intervention Type
Procedure
Intervention Name(s)
Surgical sympathectomy
Intervention Description
thoracoscopic sympathectomy
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation with phenol injection
Intervention Description
All patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection
Primary Outcome Measure Information:
Title
Temperature of the ipsilateral palm of the hand
Time Frame
For six months after the procedure
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
The level of pain based on visual analog scale (VAS) (where 0= no pain and 10= worst pain) will be assessed
Time Frame
For 24 hours after the procedure
Title
postoperative cumulative analgesic consumption
Description
Total amount of post-operative analgesics (ketorolac and fentanyl) will be recorded.
Time Frame
For 24 hours after the procedure
Title
Occurrence of pneumothorax
Description
Patients will be transferred to the PACU and chest x ray will be done to exclude pneumothorax.
Time Frame
immediately after the procedure
Title
Severity of compensatory hyperhidrosis
Description
Compensatory hyperhidrosis defined as excessive sweating after the procedures in areas of the body that previously did not sweat mainly in axilla, back, and lower limbs and will be assessed and classified into 4 degrees Not present, Mild Sometimes noticeably sweaty and sometimes not sweaty, Moderate Always aware but not troublesome, or troublesome but controlled by clothing, and Sever Causes embarrassment
Time Frame
For six months after the procedure
Title
Patient satisfaction
Description
Patient satisfaction with their procedure will be measured with a four-grade scale: 0 (not satisfied), 1 (slightly satisfied), 2 (satisfied) and 3 (very satisfied)
Time Frame
For six months after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status grades I and II
Exclusion Criteria:
Patient refusal.
Hepatic impairement.
Renal impairment.
Neuromuscular diseases.
History of opioid abuse.
Coagulopathies.
Cardiovascular diseases.
Respiratory diseases.
Previously failed cases either after percutaneous or thoracoscopic sympathectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal M El Morsy, MD
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University
City
Mansourah
State/Province
DK
ZIP/Postal Code
05
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3in Palmar Hyperhidrosis.
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