T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis

NCT04721483 | Completed DMC

• 1 other identifier: CEIm 24-02-2016
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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

Conditions

Hyperhidrosis; Compensatory Sweating; Compensatory Hyperhidrosis

Keywords

Hyperhidrosis; Ramicotomy; Sympathectomy; Sympathicotomy; Compensatory hyperhidrosis; Gustatory sweating

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• 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.

  1 year

Study Arms (2)

T3-T4 sympathicotomy

ACTIVE COMPARATOR

In this group, patients underwent a classical T3 and T4 sympathicotomy to treat primary palmar hyperhidrosis

Procedure: Ramicotomy

T3-T4 ramicotomy

EXPERIMENTAL

In this group, patients underwent a selective T3 and T4 gray ramicotomy

Procedure: Ramicotomy

Interventions

Ramicotomy PROCEDURE

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

T3-T4 ramicotomy; T3-T4 sympathicotomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Vicente Vanaclocha

Valencia, 46015, Spain

Location

Related Publications (16)

• 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.

  PMID: 9354512 BACKGROUND

• 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.

  PMID: 14703609 BACKGROUND

• 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.

  PMID: 15337046 BACKGROUND

• 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.

  PMID: 11695787 BACKGROUND

• 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.

  PMID: 14673673 BACKGROUND

• 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.

  PMID: 15296904 BACKGROUND

• 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.

  PMID: 22798011 BACKGROUND

• 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.

  PMID: 23158099 BACKGROUND

• 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.

  PMID: 29739022 BACKGROUND

• 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.

  PMID: 28273934 BACKGROUND

• 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.

  PMID: 26017654 BACKGROUND

• 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.

  PMID: 21243401 BACKGROUND

• 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.

  PMID: 31542862 BACKGROUND

• 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.

  PMID: 19631343 BACKGROUND

• Yazbek G, Wolosker N, de Campos JR, Kauffman P, Ishy A, Puech-Leao 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. doi: 10.1016/j.jvs.2005.03.041.

  PMID: 16102627 BACKGROUND

• WITTMOSER R. [Thoracoscopic sympathicotomy in circulation disorders of the arm]. Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1959;292:318-23. No abstract available. German.

  PMID: 13845515 RESULT

MeSH Terms

Conditions

Hyperhidrosis; Sweating, Gustatory

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Autonomic Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups. One with T3-T4 sympathicotomy and another with T3-T4 gray ramicotomy

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: April 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: April 1, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)