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临床试验/NCT06113978
NCT06113978已完成不适用

Fifteen Years' Experience of Thoracoscopic Sympathetic Chain Interruption for Palmar Hyperhidrosis in Children and Adolescents; Evaluation of Different Techniques

dr. Muhammad Abdelhafez Mahmoud, MD2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
420
试验地点
2
主要终点
success rate

研究概览

简要总结

In this study, the investigators aim to present fifteen years' experience of thoracoscopic sympathetic chain interruption for primary palmar hyperhidrosis in children and adolescents; evaluation of 3 different techniques (sympathectomy, sympathotomy, and clipping) regarding demographic data, surgical outcomes, complications, compensatory sweating, and patients' satisfaction.

详细描述

Primary palmar hyperhidrosis (PPH) is a severely devastating autonomic disorder that can affect any patient regardless age, even pediatrics. Thoracoscopic sympathetic chain interruption offers a definitive effective therapy. In this study, the investigators aim to assess the outcomes of thoracoscopic management of palmar hyperhidrosis in a large cohort of children younger than 18 years old with severe PPH, using sympathetic chain interruption either by sympathectomy, sympathotomy or clipping, to provide a methodology focused on the long-term outcomes of those procedures.

Patients and Methods: This is a retrospective study that included all children who underwent thoracoscopic sympathectomy, sympathotomy, or clipping for severe PPH, from April 2008 to March 2023 were assessed retrospectively. Demographic data, postoperative outcome, complications, compensatory sweating and satisfaction were analyzed.

Surgical procedures:

General anesthesia was used, with an ordinary endotracheal tube, by an experienced anesthesiologist who used one lung ventilation anesthesia to control the patient's O2-enriched ventilation in a low-volume/high-frequency technique, with alternating brief periods of apnea. The patient was placed in the semi-Fowler position, which is the dorsal decubitus position with the arms abducted and fixed at 90 degrees. The trunk was elevated by 30-40 degrees; as elevation helped displace the lungs downwards. A slight bed elevation at the knee level was useful to safely place the patients and prevent them from slipping down during the procedure.

To access the thoracic cavity, the investigators used the two-port video thoracoscopy using two 5 mm ports via 2 mini-incisions. The camera (30º scope) port was placed laterally at the fourth or fifth intercostal space (depending on the age of the patient) just posterior to the anterior axillary fold created by the pectoralis major muscle. The second port (for electrocautery instrument (hook) was laterally inserted in the third/fourth intercostal space at the mid-axillary line as that approach provides excellent aesthetic results. A CO2 pneumothorax pressure of 5-8 mmHg was used according to patient's age and body built. The posterior parietal pleura was incised just lateral to neck of 3rd rib and further dissected down to identify the thoracic sympathetic chain.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • visible exaggerated bilateral symmetrical sweating with impaired daily activities (such as shaking hands, writing and drawing),
  • without other apparent cause (e.g., hyperthyroidism, DM, or TB).

排除标准

  • secondary hyperhidrosis,
  • nocturnal sweating,
  • recurrent cases, and
  • patients older than 18 years

结局指标

主要结局

success rate

时间窗: 2 years

number of patients with post operative dry hands

compensatory sweating

时间窗: 2 years

number of patients with post operative compensatory sweating

patient satisfaction rate

时间窗: 2 years

number of patients simply questioned for outcome satisfaction (either very satisfied, satisfied, or dissatisfied)

次要结局

  • complications(2 years)
  • recurrence rate(2 years)

研究者

发起方
dr. Muhammad Abdelhafez Mahmoud, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

dr. Muhammad Abdelhafez Mahmoud, MD

Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine

Al-Azhar University

研究点 (2)

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