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Trial record 21 of 178 for:    "Sweat Gland Disease"

Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3in Palmar Hyperhidrosis.

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ClinicalTrials.gov Identifier: NCT03506828
Recruitment Status : Enrolling by invitation
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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.


Condition or disease Intervention/treatment Phase
Excessive Sweating of the Hands Procedure: Surgical sympathectomy Procedure: Radiofrequency ablation with phenol injection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Single blind (Investigator) study
Primary Purpose: Treatment
Official Title: The Effect of Adding Phenol With Fluoroscopy Guided Radiofrequency Ablation of T2-T3 Versus Thoracoscopic Sympathectomy in Palmar Hyperhidrosis.
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Surgical sympathectomy
All patients in this group will have standard surgical procedure
Procedure: Surgical sympathectomy
thoracoscopic sympathectomy

Active Comparator: Radiofrequency ablation with phenol injection
patient will receive radiofrequency ablation of T2 and T3 sympathetic ganglia + phenol 6% (0.5ml) injection
Procedure: Radiofrequency ablation with phenol injection
All patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection




Primary Outcome Measures :
  1. Temperature of the ipsilateral palm of the hand [ Time Frame: For six months after the procedure ]

Secondary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: For 24 hours after the procedure ]
    The level of pain based on visual analog scale (VAS) (where 0= no pain and 10= worst pain) will be assessed

  2. postoperative cumulative analgesic consumption [ Time Frame: For 24 hours after the procedure ]
    Total amount of post-operative analgesics (ketorolac and fentanyl) will be recorded.

  3. Occurrence of pneumothorax [ Time Frame: immediately after the procedure ]
    Patients will be transferred to the PACU and chest x ray will be done to exclude pneumothorax.

  4. Severity of compensatory hyperhidrosis [ Time Frame: For six months after the procedure ]
    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

  5. Patient satisfaction [ Time Frame: For six months after the procedure ]
    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)



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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506828


Locations
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Egypt
Mansoura University
Mansourah, DK, Egypt, 05
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Gamal M El Morsy, MD Professor of Anesthesia and Surgical Intensive Care

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03506828     History of Changes
Other Study ID Numbers: MFM-IRB, MD/17.11.08
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Phenol
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions