Excessive Sweating of the HandsNCT03506828
Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3in Palmar Hyperhidrosis.
A study testing Surgical sympathectomy and Radiofrequency ablation with phenol injection in people with Excessive Sweating of the Hands, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Excessive Sweating of the Hands
- What is being tested?
- Surgical sympathectomy and Radiofrequency ablation with phenol injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 2 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status grades I and II
Who cannot join
- Patient refusal.
- Hepatic impairement.
- Renal impairment.
- Neuromuscular diseases.
- History of opioid abuse.
- Coagulopathies.
Show all 9Show fewer
- Cardiovascular diseases.
- Respiratory diseases.
- Previously failed cases either after percutaneous or thoracoscopic sympathectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3 Versus Thoracoscopic Sympathectomy in Palmar Hyperhidrosis.
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.
Read more
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.
Read the 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.
- Conditions
- Excessive Sweating of the Hands
- Being tested
- Surgical sympathectomy, Radiofrequency ablation with phenol injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical sympathectomyProcedure or surgery
thoracoscopic sympathectomy
Radiofrequency ablation with phenol injectionProcedure or surgery
All patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection
| Study group | Role | What they receive |
|---|---|---|
| Surgical sympathectomy | Active comparator | All patients in this group will have standard surgical procedure Receives: Procedure: Surgical sympathectomy |
| Radiofrequency ablation with phenol injection | Active comparator | patient will receive radiofrequency ablation of T2 and T3 sympathetic ganglia + phenol 6% (0.5ml) injection Receives: Procedure: Radiofrequency ablation with phenol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature of the ipsilateral palm of the hand
Measured: For six months after the procedure
Secondary outcomes (5)
Postoperative pain scores
The level of pain based on visual analog scale (VAS) (where 0= no pain and 10= worst pain) will be assessed
Measured: For 24 hours after the procedure
postoperative cumulative analgesic consumption
Total amount of post-operative analgesics (ketorolac and fentanyl) will be recorded.
Measured: For 24 hours after the procedure
Occurrence of pneumothorax
Patients will be transferred to the PACU and chest x ray will be done to exclude pneumothorax.
Measured: immediately after the procedure
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
Measured: For six months after the procedure
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)
Measured: For six months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Feb 2018
- Primary completion31 Jan 2019 (estimated)
- Study completion2 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Sweating of the HandsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gamal M El Morsy, MD, Study chair, Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506828
- Sponsor's protocol ID
- MFM-IRB, MD/17.11.08
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3 Versus Thoracoscopic Sympathectomy in Palmar Hyperhidrosis.
- ClinicalTrials.gov ID
- NCT03506828
- Acronym / sponsor ID
- MFM-IRB, MD/17.11.08
- Conditions
- Excessive Sweating of the Hands
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 2 Jan 2020 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical sympathectomy | Active comparator | Procedure: Surgical sympathectomyAll patients in this group will have standard surgical procedure |
| Radiofrequency ablation with phenol injection | Active comparator | Procedure: Radiofrequency ablation with phenol injectionpatient will receive radiofrequency ablation of T2 and T3 sympathetic ganglia + phenol 6% (0.5ml) injection |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status grades I and II
Key exclusion criteria (9 listed)
- Patient refusal.
- Hepatic impairement.
- Renal impairment.
- Neuromuscular diseases.
- History of opioid abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical sympathectomythoracoscopic sympathectomy | Procedure or surgery | Surgical sympathectomy |
| Radiofrequency ablation with phenol injectionAll patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection | Procedure or surgery | Radiofrequency ablation with phenol injection |
Primary outcome
Temperature of the ipsilateral palm of the hand
Time frame: For six months after the procedure
5 secondary outcomes
Postoperative pain scores
Time frame: For 24 hours after the procedure
postoperative cumulative analgesic consumption
Time frame: For 24 hours after the procedure
Occurrence of pneumothorax
Time frame: immediately after the procedure
Severity of compensatory hyperhidrosis
Time frame: For six months after the procedure
Patient satisfaction
Time frame: For six months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal M El Morsy, MD study chair
Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical sympathectomy and Radiofrequency ablation with phenol injection in people with Excessive Sweating of the Hands, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature of the ipsilateral palm of the hand (time frame: For six months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.