NCT04721483: T3-T4RY

T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis

Completed NA Last updated 22 January 2021

What this trial tests

NA trial testing Ramicotomy in Hyperhidrosis in 42 participants. Completed in 1 April 2020.

Timeline

1 April 2016

Primary endpoint
1 October 2019

1 April 2020

Quick facts

Lead sponsor	University of Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	42
Start date	1 April 2016
Primary completion	1 October 2019
Estimated completion	1 April 2020
Sites	2 locations across Spain

Drugs / interventions tested

• Ramicotomy

Conditions studied

• Hyperhidrosis — all drugs for Hyperhidrosis →
• Compensatory Sweating — all drugs for Compensatory Sweating →
• Compensatory Hyperhidrosis — all drugs for Compensatory Hyperhidrosis →

Sponsor

University of Valencia

Who can join

Adults 18 to 60, any sex, with Hyperhidrosis or Compensatory Sweating. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Selective T₃-T₄ sympathicotomy versus gray ramicotomy on outcome and quality of life in hyperhidrosis patients: a randomized clinical trial.
   Vanaclocha V, Guijarro-Jorge R, Saiz-Sapena N, Granell-Gil M, et al · · 2021 · cited 6× · PMID 34475473 · DOI 10.1038/s41598-021-96972-7