About this trial
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection in the treatment of gynecomastia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male patients, aged 18-75 years old;
Preoperative breast ultrasound indicates male breast development, and breast enlargement symptoms persist for more than 1 year;
Primary male breast development that has been unresponsive to drug treatment, or those who refuse drug treatment;
According to Gynecomastia's surgical indications, refer to the "2023 Expert consensus on the clinicaldiagnosis and treatment of gynecomastia in China" Simon grading of male breast development IIb or above;
Disqualifiers
Age<16 years old, still in puberty, or disease duration ≤ 1 year;
Simple obesity, no obvious glandular tissue was found on breast ultrasound examination;
Male patients with breast developmental disorders secondary to other diseases;
Patients with contraindications for general anesthesia surgery such as coagulation dysfunction and severe cardiovascular disease, who cannot tolerate surgery;
Trial design
Single group
Treatments tested in this trial
Single-port Robotic-assisted Subcutaneous Gland Resection in males
Procedure/SurgerySingle-port Robotic-assisted Subcutaneous Gland Resection for males in the treatment of gynecomastia.
Treatment groups
Trial outcomes
Primary outcomes
Patient's and doctor's satisfaction
Use the Health Status Survey Questionnaire (SF-36) to assess the general condition of patients.
Patient's psychological status using the Self Rating Anxiety Scale (SAS)
Use the Self Rating Anxiety Scale (SAS) to assess the psychological status of patients.
Patient's psychological status
Use the Self Rating Depression Scale (SDS) to assess the psychological status of patients.
Patient's sensory
Using Semmes Weinstein (S-W) monofilament to detect postoperative sensory recovery in patients.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: