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T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis

NCT04721483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-01-22

No results posted yet for this study

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

Conditions

  • Hyperhidrosis
  • Compensatory Sweating
  • Compensatory Hyperhidrosis

Interventions

PROCEDURE

Ramicotomy

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

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2019-10-01
Completion
2020-04-01

Countries

  • Spain

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 NCT04721483 on ClinicalTrials.gov