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

NCT03506828 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2018-04-24

No results posted yet for this study

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.

Conditions

  • Excessive Sweating of the Hands

Interventions

PROCEDURE

Surgical sympathectomy

thoracoscopic sympathectomy

PROCEDURE

Radiofrequency ablation with phenol injection

All patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Gamal M El Morsy, MD · Professor of Anesthesia and Surgical Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-01-31
Completion
2020-01-02

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03506828 on ClinicalTrials.gov