An interventional study of Thoracic Sympathectomy in Hyperhidrosis Primary Focal Palms, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Sohag University · Not applicable, Interventional, and Health services research
The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles.
The aims of this study are:
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is a prospective clinical study that includes all patients with Primary Focal Hyperhidrosis, who will be operated on with Bilateral Thoracoscopic Sympathectomy.
Procedure: Thoracic Sympathectomy
Bilateral thoracoscopic sympathectomy will be performed with general anesthesia, using single lung ventilation and monopolar cautery for transection of the sympathetic chain. Persons with PFH who underwent the BTS were classified into three groups, depending the level of transaction of sympathetic chain: 1. transection at the level from the second to the forth thoracic sympathetic ganglion (T2- T4); 2. transection at the level from the third to the forth thoracic sympathetic ganglion (T3-T4) 3. transection at the level from the second to the third thoracic sympathetic ganglion (T2-T3)..
Also known as: Bilateral Thoracoscopic Sympathectomy
Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing
Participants will be assessed using the HDSS and gravimetric sweat testing. A reduction of ≥ 2 points in HDSS score or a ≥ 50% reduction in sweat production will be considered a successful outcome. Data will be aggregated as the proportion of participants achieving these reductions.
Time frame: Immediately After surgery
Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI)
The DLQI will be administered preoperatively and at 3 months postoperatively to evaluate changes in quality of life. The DLQI is a 10-item questionnaire where higher scores indicate greater impairment. The primary endpoint will be the mean reduction in DLQI score from baseline to 3 months, with a reduction of ≥ 5 points considered clinically significant
Time frame: From baseline to 3 months post-operation.
Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS)
Postoperative pain will be assessed at regular intervals (1 day, 1 week, and 1 month post-surgery) using the Visual Analog Scale (VAS), a 10-point scale where 0 indicates no pain and 10 indicates severe pain. The primary endpoint will be the mean VAS score at each time point, with pain reduction over time compared
Time frame: From 1 day post-operation to 1 month post-operation.
Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
Participants will report compensatory sweating at 1 month and 3 months post-surgery using the HDSS. The severity of compensatory sweating will be recorded with a scale ranging from 1 (no symptoms) to 4 (severe symptoms that interfere with daily activities). The primary endpoint will be the percentage of patients reporting compensatory sweating and their scores on the HDSS at 3 months
Time frame: from time of operation for 3 months after operation
Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)
Participants will report compensatory sweating at 1 month and 3 months post-surgery using the HDSS. The severity of compensatory sweating will be recorded with a scale ranging from 1 (no symptoms) to 4 (severe symptoms that interfere with daily activities). The primary endpoint will be the percentage of patients reporting compensatory sweating and their scores on the HDSS at 3 months
Time frame: From baseline to 3 months post-operation.
Plan to share: Undecided
Started Jan 2024 (actual). Primary completion is estimated for Apr 2025, 15 months after the start.
Of 20 interventional studies with no phase under Hyperhidrosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.