Hamilton Niura Noro, Tedde Miguel Lia, Wolosker Nelson, Aguiar Wolfgang William Schmidt, Ferreira Hylas Paiva da Costa, Oliveira Humberto Alves de, Lima Alexandre Marcelo Rodrigues, Westphal Fernando Luiz, Oliveira Marina Varela Braga de, Riuto Fabio de Oliveira, Pereira Sergio Tadeu Lima F, Rezende Guilherme Cançado, Valero Caroline Elizabeth Brero, Pego-Fernandes Paulo M
Heart Institute (InCor) Hospital das Clinicas, University of Sao Paulo, R. Dr. Eneas de Carvalho Aguiar, 44, 05403-900, Sao Paulo, SP, Brazil.
Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815, 01327-001, São Paulo, SP, Brazil.
Contemp Clin Trials Commun. 2020 Jul 15;19:100618. doi: 10.1016/j.conctc.2020.100618. eCollection 2020 Sep.
To evaluate the contribution that unilateral thoracic sympathectomy in dominant side or two-stage bilateral thoracic sympathectomy can have as strategies to reduce the incidence of compensatory sweating after sympathectomy for palmar hyperhidrosis.
This is a prospective, controlled, randomized multicenter trial of 200 participants with palmar hyperhidrosis, which will be randomized into two arms: (a) one-stage bilateral thoracic sympathectomy (control arm); or (b) unilateral thoracic sympathectomy in dominant side (intervention arm). At six months the participants submitted to unilateral procedure can make the contralateral surgery if they wanted it, creating a third group called two-stage bilateral sympathectomy. Participants will be evaluated for the degree of sweating by the Hyperhidrosis Disease Severity Scale (HDSS) and of quality of life questionnaires.
96 participants out of the 200 proposed have been included so far, with 48 participants randomized to each arm. From the sample 61 (63.5%) are female, with a mean age of 24 (20-32) years. There were exclusive palmar hiperhydrosis in 14 cases (14.5%), palmar and plantar hyperhidrosis in 36 (37.5%) cases, palmar and axillar hyperhidrosis in 12 (12,5%) cases and palmar-axillary-plantar hyperhidrosis in 34 (35,4%) cases. The age at the beginning of the disease was childhood (78%), with mean of time of disease 15 (11-22) years.
If one or both hypothesis: (a) unilateral sympathectomy in dominant hand is a satisfactory treatment; b) two-stage bilateral sympathectomy causes less compensatory sweating than in one stage are confirmed there is a chance that surgical therapy for palmar hyperhidrosis can be changed for better.
评估优势侧单侧胸交感神经切除术或两阶段双侧胸交感神经切除术作为减少手掌多汗症交感神经切除术后代偿性出汗发生率的策略所具有的作用。
这是一项针对200名手掌多汗症患者的前瞻性、对照、随机多中心试验，将患者随机分为两组：(a) 一期双侧胸交感神经切除术（对照组）；或(b) 优势侧单侧胸交感神经切除术（干预组）。在六个月时，接受单侧手术的参与者如果愿意可以进行对侧手术，从而形成第三组，即两阶段双侧交感神经切除术。将通过多汗症疾病严重程度量表（HDSS）和生活质量问卷对参与者的出汗程度进行评估。
到目前为止，在计划的200名参与者中已纳入96名，每组随机分配48名参与者。样本中61名（63.5%）为女性，平均年龄24岁（20 - 32岁）。单纯手掌多汗症14例（14.5%），手掌和足底多汗症36例（37.5%），手掌和腋窝多汗症12例（12.5%），手掌 - 腋窝 - 足底多汗症34例（35.4%）。疾病开始于儿童期的占78%，疾病平均持续时间为15年（11 - 22年）。
如果以下一个或两个假设得到证实：(a) 优势手单侧交感神经切除术是一种令人满意的治疗方法；(b) 两阶段双侧交感神经切除术引起的代偿性出汗比一期手术少，那么手掌多汗症的手术治疗有可能得到改善。
