To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males

ConditionGynecomastia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age17-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Single-port Robotic-assisted Subcutaneous Gland Resection in males

    Procedure/Surgery

    Single-port Robotic-assisted Subcutaneous Gland Resection for males in the treatment of gynecomastia.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: the single-port robotic-assisted subcutaneous gland resection groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient's and doctor's satisfaction

Use the Health Status Survey Questionnaire (SF-36) to assess the general condition of patients.

Time frame
2 years
2

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.

Time frame
2 years
3

Patient's psychological status

Use the Self Rating Depression Scale (SDS) to assess the psychological status of patients.

Time frame
2 years
4

Patient's sensory

Using Semmes Weinstein (S-W) monofilament to detect postoperative sensory recovery in patients.

Time frame
2 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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