CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Ramicotomyprocedure
Likely dose
Not stated in record
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Search/NCT04721483
NCT04721483N/ACompleted

Selective T3-T4 Sympathicotomy Versus Gray Ramicotomy on Outcome and Quality of Life in Hyperhidrosis Patients. A Randomized Clinical Trial

University of Valencia·interventional·Posted Jan 22, 2021·Updated Jan 22, 2021

In Brief

A clinical study evaluating Ramicotomy for Hyperhidrosis and 2 related conditions. Completed, enrolled 42 participants across 2 sites.

Detailed Summary

It is presented a further refinement in palmar hyperhidrosis's surgical treatment to improve results and reduce side effects, mainly compensatory hyperhidrosis. It seems that a more selective sympathetic system lesion, namely a selective T3 and T4 gray rami communicantes lesion, allows retaining some residual sweating in the hands without inducing compensatory sweating in the abdomen, thighs, and feet. The result is greater patient satisfaction. There has been a long journey since Wittmosser et al. suggested the technique of gray and white ramicotomy in 1992. In this way, the attending physicians have refined the surgical procedure progressively. The two last research groups reporting their results with selective gray ramicotomy (the idea now is not to lesion the white rami communicantes) entailed extensive lesions (T2 to T4/T5). This study shows that a more selective T3 and T4 selective gray ramicotomy achieves excellent results with fewer side effects. Thus, it is a further step toward improving outcomes, reducing side effects, and increasing patients' satisfaction. Additionally, the present work has concentrated on objective ways to measure compensatory hyperhidrosis by measuring the sweat production in milliliters of water and the temperature changes in degrees Celsius. This accurate measurement removes the subjectivity induced when we base the results on the treating physicians' opinions or the patients themselves. The objective measurement of the sweat production in milliliters of water and temperature rise in degrees Celsius has allowed the research group to reach conclusions independent of opinions both from treating physicians and patients themselves. Also, a more selective gray rami communicantes lesion can achieve better results with less compensatory hyperhidrosis and with better patient's satisfaction

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 22, 2021
Enrollment StartApr 1, 2016
Primary CompletionOct 1, 2019
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.4 years ago

Interventions

Ramicotomyprocedure

We will selectively lesion the gray rami communicantes from T3 and T4 thoracic sympathetic ganglia