T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis (T3-T4RY)
Primary Purpose
Hyperhidrosis, Compensatory Sweating, Compensatory Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ramicotomy
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring Hyperhidrosis, Ramicotomy, Sympathectomy, Sympathicotomy, Compensatory hyperhidrosis, Gustatory sweating
Eligibility Criteria
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
Sites / Locations
- Hospital General Universitario de Valencia
- Vicente Vanaclocha
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
T3-T4 sympathicotomy
T3-T4 ramicotomy
Arm Description
In this group, patients underwent a classical T3 and T4 sympathicotomy to treat primary palmar hyperhidrosis
In this group, patients underwent a selective T3 and T4 gray ramicotomy
Outcomes
Primary Outcome Measures
Compensatory sweating
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
Postoperative quality of life
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04721483
First Posted
January 19, 2021
Last Updated
January 21, 2021
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT04721483
Brief Title
T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis
Acronym
T3-T4RY
Official Title
Selective T3-T4 Sympathicotomy Versus Gray Ramicotomy on Outcome and Quality of Life in Hyperhidrosis Patients. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Compensatory Sweating, Compensatory Hyperhidrosis
Keywords
Hyperhidrosis, Ramicotomy, Sympathectomy, Sympathicotomy, Compensatory hyperhidrosis, Gustatory sweating
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups. One with T3-T4 sympathicotomy and another with T3-T4 gray ramicotomy
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients distributed in a prospective randomized fashion between two groups. We calculated the sample size based on previous research and used a block randomization model. We took eight blocks of four and two blocks of five patients with a random distribution of two patients from each group. This project was blind.
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T3-T4 sympathicotomy
Arm Type
Active Comparator
Arm Description
In this group, patients underwent a classical T3 and T4 sympathicotomy to treat primary palmar hyperhidrosis
Arm Title
T3-T4 ramicotomy
Arm Type
Experimental
Arm Description
In this group, patients underwent a selective T3 and T4 gray ramicotomy
Intervention Type
Procedure
Intervention Name(s)
Ramicotomy
Intervention Description
We will selectively lesion the gray rami communicantes from T3 and T4 thoracic sympathetic ganglia
Primary Outcome Measure Information:
Title
Compensatory sweating
Description
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
Time Frame
1 year
Title
Postoperative quality of life
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Vicente Vanaclocha
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9354512
Citation
Gossot D, Toledo L, Fritsch S, Celerier M. Thoracoscopic sympathectomy for upper limb hyperhidrosis: looking for the right operation. Ann Thorac Surg. 1997 Oct;64(4):975-8. doi: 10.1016/s0003-4975(97)00799-6.
Results Reference
background
PubMed Identifier
14703609
Citation
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. doi: 10.3349/ymj.2003.44.6.1008.
Results Reference
background
PubMed Identifier
15337046
Citation
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. doi: 10.1016/j.athoracsur.2004.03.034.
Results Reference
background
PubMed Identifier
11695787
Citation
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.
Results Reference
background
PubMed Identifier
14673673
Citation
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. doi: 10.1007/s10286-003-1115-1.
Results Reference
background
PubMed Identifier
15296904
Citation
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. doi: 10.1016/j.ejcts.2004.04.030.
Results Reference
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PubMed Identifier
22798011
Citation
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.
Results Reference
background
PubMed Identifier
23158099
Citation
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.
Results Reference
background
PubMed Identifier
29739022
Citation
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.
Results Reference
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PubMed Identifier
28273934
Citation
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.
Results Reference
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PubMed Identifier
26017654
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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Citation
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Results Reference
result
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T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis
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