This prospective, single-center observational study evaluates the clinical utility of intraoperative sympathetic nerve width measurement during thoracoscopic sympathectomy (ETS) for palmar/craniofacial hyperhidrosis (PH/CH) and facial blushing (FF). The study aims to correlate nerve width-measured using a novel Rapid Intraoperative Sympathetic Nerve Width System (RMSNW-OS) (±0.2mm precision)-with surgical outcomes, compensatory sweating rates, patient satisfaction, and 12-month efficacy.
Approximately 1,000 patients (aged 18-55) will undergo standardized ETS at Shanghai First People's Hospital (2025-2029). Objective metrics include thermographic (palmar/forehead temperature), hemodynamic (HR/BP), biochemical (catecholamines), and Doppler flow measurements. Patient-reported outcomes use diagnosis-specific binary questionnaires and the Hyperhidrosis Disease Severity Scale (HDSS).
Statistical analysis will determine if nerve width predicts treatment response. Innovations include RMSNW-OS standardization and a multidimensional assessment framework to optimize ETS precision and patient quality of life.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria:
1. Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing).
2. Age : ≥18 years and ≤55 years.
3. Cardiopulmonary Function :
Normal preoperative chest CT scan and electrocardiogram (ECG).
4. Performance Status : ECOG score (see Attachment 1) of 0-1, indicating good clinical fitness and ability to perform daily activities independently.
5. Informed Consent : Patients and their families fully understand the study's purpose, procedures, risks, and potential benefits, voluntarily sign the Informed Consent Form, and agree to participate.
Exclusion Criteria:
1\. Abnormal Preoperative ECG :
1. Severe arrhythmias:
1. Type II second-degree or higher atrioventricular block.
2. Symptomatic ventricular arrhythmias.
3. Uncontrolled supraventricular arrhythmias (resting heart rate \>100 bpm). These may cause inadequate cardiac output, hypoperfusion of vital organs, and increased surgical risk.
2. Myocardial ischemia or infarction:
1. ECG showing ST-segment elevation/depression, T-wave inversion.
2. Pathological Q-waves indicating myocardial infarction. 2. Abnormal Chest CT :
1\) Severe pulmonary infections (e.g., lobar pneumonia, empyema) with symptoms like fever, cough, dyspnea. Surgery increases infection risk and may lead to atelectasis or respiratory failure.
2\) Pneumothorax or tension pneumothorax:
1. Significant lung collapse causing dyspnea.
2. Tension pneumothorax requiring immediate chest tube drainage. 3) Pleural effusion (moderate/large volume): Causes dyspnea or mediastinal shift; surgery may worsen respiratory function.
3\. Hyperthyroidism-induced facial blushing or generalized hyperhidrosis. 4. Anesthesia Contraindications : Allergy to anesthetics or high-risk conditions (severe pulmonary/cardiac dysfunction).
5\. Cognitive/Psychiatric Impairment : Inability to provide informed consent or understand study risks.
6\. Non-Compliance with Follow-up : Inability to adhere to postoperative visits.
7\. Immunodeficiency Disorders : Severe immunodeficiency, AIDS, or organ transplant history.
8\. Frailty/Advanced Age : Elderly patients with comorbidities or functional decline unfit for surgery.
9\. Severe Organ Dysfunction : Cirrhosis, renal failure, or inability to tolerate surgery/recovery.
10\. Active Infections : Under antibiotic treatment for pneumonia, tuberculosis, or bacterial infections.
11\. Uncontrolled Diabetes : Poor glycemic control with complications (retinopathy, diabetic foot).
12\. Concurrent Clinical Trials : Participation in other interventional studies affecting results.
13\. Severe Malnutrition : Significant weight loss or nutritional deficiency increasing anesthesia/surgical risks.
14\. Hematologic Disorders : Anemia, thrombocytopenia, or coagulopathies affecting hemostasis/recovery.
15\. Severe Chronic Respiratory Failure : Long-term ventilator dependence or tracheostomy.
Primary outcome measure(s)
Intraoperative Sympathetic Nerve Width — Intraoperative (Day 0) Quantitative measurement (mm) of thoracic sympathetic nerve trunks (T2 for craniofacial hyperhidrosis/facial blushing; T4 for facial blushing), using the Rapid Measurement System (RMSNW-OS). Measurement based on thoracoscopic image pixel ratios. Method: Calibrated electrosurgical hook with 5 mm reference; width calculated from still-frame images. Precision: ±0.2 mm.
Predictive Value of Nerve Width for Surgical Success — through study completion, an average of 1 year Assess whether intraoperative sympathetic nerve width (mm) predicts surgical success, defined as ≥50% symptom reduction based on the Hyperhidrosis Disease Severity Scale (HDSS). Analysis Method: ROC curve analysis.
Predictive Value of Nerve Width for Compensatory Hyperhidrosis — through study completion, an average of 1 year Assess whether intraoperative sympathetic nerve width (mm) predicts the incidence of clinically significant compensatory hyperhidrosis requiring intervention. Analysis Method: ROC curve analysis.
Symptom Recurrence Rate — 6/12 months post-op vs. 1-month baseline. Proportion of patients reporting recurrence of primary symptoms (palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing) at follow-up.
Sustained Quality of Life Improvement — 6/12 months post-op vs. 1-month baseline. Improvement in patient-reported quality of life scores, measured by validated questionnaires, compared to 1-month postoperative baseline.
Palmar/Forehead Temperature Change — Baseline (pre-op), 1/3/6/12 months post-op. ∆ Temperature (°C) pre- vs. post-surgery measured by standardized infrared thermometer. Reflects sympathetic denervation effect on peripheral circulation.
Patient Satisfaction — 1/3/6/12 months post-op. Proportion of patients reporting improvement in social confidence, daily functioning, and symptom burden using binary (yes/no) responses from diagnosis-specific questionnaires. Unit of Measure: Percentage of patients responding "Yes"
Hyperhidrosis Disease Severity Scale (HDSS) Score — 1/3/6/12 months post-op. Change in HDSS score (scale 1-4) to assess severity of hyperhidrosis and its impact on daily life. Unit of Measure: Units on a 4-point scale.
Compensatory Hyperhidrosis Rate — 1/3/6/12 months post-op. Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).
Trial sites (1)
Facility
City
Region
Status
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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