- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721483
T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis (T3-T4RY)
Selective T3-T4 Sympathicotomy Versus Gray Ramicotomy on Outcome and Quality of Life in Hyperhidrosis Patients. A Randomized Clinical Trial
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 Overview
Status
Intervention / Treatment
Detailed Description
Ever since the introduction of thoracic sympathectomy in the treatment of palmar and axillary hyperhidrosis, there has been a continuous quest to find a way to reduce its most unpleasant side effect: compensatory hyperhidrosis (CH). Following the idea of minimizing the surgically induced damage to the sympathetic chain, Wittmoser introduced in 1992, the ramicotomy technique. It entailed the selective lesion of the rami communicantes, both white and gray, from T2 to T4-T5. This surgical technique was not as selective as expected because it damaged the sympathetic input for the lungs and heart, and the head and face. Wittmoser described this surgical technique but never published any results. Gossot4 in 1997 compared this technique with the sympathectomy of the same ganglia in 54 patients. He found that CH's incidence was the same in both groups, but the severity was less in the ramicotomy than in the sympathectomy group. The recurrence rate was more prominent in the first than in the second group (5% ramicotomy versus 0% sympathectomy). Other researchers have confirmed these results.
More studies compared the sympathectomy with the ramicotomy in the following years, confirming that ramicotomy has a lower incidence of CH5-10, with less dry hands but with some recurrences.
In a step forward, Coveliers et al.11 lesioned only the T2 T3 and T4 gray rami communicantes, not touching the sympathetic chain or the white rami communicantes, with CH dropping to 7.2% and no recurrences. Akil et al.12 reported the lesion of the T2-T5 gray rami communicantes with no CH and again with no recurrences. Both studies entail a more extensive lesion, including T2, and one of those studies, T5. There is an agreement to avoid lesioning T2 in many previous reports to reduce the incidence and severity of CH.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Valencia, Spain, 46014
- Hospital General Universitario de Valencia
-
Valencia, Spain, 46015
- Vicente Vanaclocha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- palmar HH with or without axillary HH refractive to conservative treatments
- or reluctant to continue with them after six months and willing to undergo surgical treatment,
- Hyperhidrosis Disease Severity Score grade D
Exclusion Criteria:
- previous thoracic pathology (lung infections, particularly pulmonary empyema, pneumothorax, hemothorax, rib fractures, neoplasms)
- heart failure
- hypothyroidism
- tuberculosis
- bradycardia (40 pulsations/min)
- alcoholism
- drug addiction
- BMI >30
- pregnancy
- generalized HH or related to any health disorder
- comorbidities
- or medication intake that induces excessive sweating
- patients with primary facial or plantar HH
- patients not complying with follow-ups
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: T3-T4 sympathicotomy
In this group, patients underwent a classical T3 and T4 sympathicotomy to treat primary palmar hyperhidrosis
|
We will selectively lesion the gray rami communicantes from T3 and T4 thoracic sympathetic ganglia
|
Experimental: T3-T4 ramicotomy
In this group, patients underwent a selective T3 and T4 gray ramicotomy
|
We will selectively lesion the gray rami communicantes from T3 and T4 thoracic sympathetic ganglia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compensatory sweating
Time Frame: 1 year
|
We will measure the increase in sweating in the chest, abdomen thighs and feet by capturing the sweat produced in these body areas in a period of 15 minutes in a closed room at 25ºC and 85% humidity.
The sweat will be captured with a special cellulose pad and these pads will be weighted with a precision scale before and after being placed in the body areas to be analysed.
The sweat production will be known by the milliliters of water captured in the pads used to capture it
|
1 year
|
Postoperative quality of life
Time Frame: 1 year
|
We will compare with a questionnaire that patients will fulfill baseline and in every follow-up visit on the quality of life.
It will be used the quality of life questionnaire developed by Amir M, Arish A, Weinstein Y, Pfeffer M, Levy Y. Impairment in quality of life among patients seeking surgery for hyperhidrosis (excessive sweating): preliminary results.
Isr J Psychiatry Relat Sci.
2000;37(1):25-31.
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gossot D, Toledo L, Fritsch S, Célérier M. Thoracoscopic sympathectomy for upper limb hyperhidrosis: looking for the right operation. Ann Thorac Surg. 1997 Oct;64(4):975-8.
- Cho HM, Chung KY, Kim DJ, Lee KJ, Kim KD. The comparison of VATS ramicotomy and VATS sympathicotomy for treating essential hyperhidrosis. Yonsei Med J. 2003 Dec 30;44(6):1008-13.
- Lee DY, Kim DH, Paik HC. Selective division of T3 rami communicantes (T3 ramicotomy) in the treatment of palmar hyperhidrosis. Ann Thorac Surg. 2004 Sep;78(3):1052-5.
- Cheng YJ, Wu HH, Kao EL. Video-assisted thoracoscopic sympathetic ramicotomy for hyperhidrosis--a way to reduce the complications. Ann Chir Gynaecol. 2001;90(3):172-4.
- Lee DY, Paik HC, Kim DH, Kim HW. Comparative analysis of T3 selective division of rami communicantes (ramicotomy) to T3 sympathetic clipping in treatment of palmar hyperhidrosis. Clin Auton Res. 2003 Dec;13 Suppl 1:I45-7.
- Kim DY, Paik HC, Lee DY. Comparative analysis of T2 selective division of rami-communicantes (ramicotomy) with T2 sympathetic clipping in the treatment of craniofacial hyperhidrosis. Eur J Cardiothorac Surg. 2004 Aug;26(2):396-400.
- Hwang JJ, Kim DH, Hong YJ, Lee DY. A comparison between two types of limited sympathetic surgery for palmar hyperhidrosis. Surg Today. 2013 Apr;43(4):397-402. doi: 10.1007/s00595-012-0246-1. Epub 2012 Jul 15.
- Coveliers H, Meyer M, Gharagozloo F, Wisselink W, Rauwerda J, Margolis M, Tempesta B, Strother E. Robotic selective postganglionic thoracic sympathectomy for the treatment of hyperhidrosis. Ann Thorac Surg. 2013 Jan;95(1):269-74. doi: 10.1016/j.athoracsur.2012.08.013. Epub 2012 Nov 14.
- Akil A, Semik M, Fischer S. Efficacy of Miniuniportal Video-Assisted Thoracoscopic Selective Sympathectomy (Ramicotomy) for the Treatment of Severe Palmar and Axillar Hyperhidrosis. Thorac Cardiovasc Surg. 2019 Aug;67(5):415-419. doi: 10.1055/s-0038-1642030. Epub 2018 May 8.
- Zhang W, Yu D, Wei Y, Xu J, Zhang X. A systematic review and meta-analysis of T2, T3 or T4, to evaluate the best denervation level for palmar hyperhidrosis. Sci Rep. 2017 Mar 9;7(1):129. doi: 10.1038/s41598-017-00169-w. Review.
- Cai SW, Shen N, Li DX, Wei B, An J, Zhang JH. Compensatory sweating after restricting or lowering the level of sympathectomy: a systematic review and meta-analysis. Clinics (Sao Paulo). 2015 Mar;70(3):214-9. doi: 10.6061/clinics/2015(03)11. Epub 2015 Mar 1. Review.
- Scognamillo F, Serventi F, Attene F, Torre C, Paliogiannis P, Pala C, Trignano E, Trignano M. T2-T4 sympathectomy versus T3-T4 sympathicotomy for palmar and axillary hyperhidrosis. Clin Auton Res. 2011 Apr;21(2):97-102. doi: 10.1007/s10286-010-0110-6. Epub 2011 Jan 19.
- Dogru MV, Sezen CB, Girgin O, Cansever L, Kocaturk CI, Metin M, Dincer SI. Is there any relationship between quality of life and the level of sympathectomy in primary palmar hyperhidrosis? Single-center experience. Gen Thorac Cardiovasc Surg. 2020 Mar;68(3):273-279. doi: 10.1007/s11748-019-01210-7. Epub 2019 Sep 21.
- Weksler B, Blaine G, Souza ZB, Gavina R. Transection of more than one sympathetic chain ganglion for hyperhidrosis increases the severity of compensatory hyperhidrosis and decreases patient satisfaction. J Surg Res. 2009 Sep;156(1):110-5. doi: 10.1016/j.jss.2009.04.015. Epub 2009 May 14.
- Yazbek G, Wolosker N, de Campos JR, Kauffman P, Ishy A, Puech-Leão P. Palmar hyperhidrosis--which is the best level of denervation using video-assisted thoracoscopic sympathectomy: T2 or T3 ganglion? J Vasc Surg. 2005 Aug;42(2):281-5.
- WITTMOSER R. [Thoracoscopic sympathicotomy in circulation disorders of the arm]. Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1959;292:318-23. German.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIm 24-02-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperhidrosis
-
Atacama TherapeuticsCompletedPalmar HyperhidrosisUnited States
-
Miramar LabsCompletedAxillary HyperhidrosisCanada
-
Commons Aesthetic Plastic SurgerySound Surgical Technologies, LLC.CompletedAxillary HyperhidrosisUnited States
-
Cynosure, Inc.CompletedHYPERHIDROSISUnited States
-
Botanix PharmaceuticalsCompletedAxillary HyperhidrosisUnited States
-
miraDry, Inc.Withdrawn
-
Botanix PharmaceuticalsCompletedAxillary HyperhidrosisUnited States
-
Northwestern UniversityCompletedAxillary HyperhidrosisUnited States
-
Ulthera, IncCompletedAxillary HyperhidrosisGermany
-
Peking University People's HospitalBeijing Municipal Science & Technology CommissionCompleted