The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
NCT Number: NCT06286150
Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
consent, either by the subject or their guardian.
Exclusion criteria
SHURUI Single-port surgical robot system
Time frame: Within 1 day after surgery
The conversion from a single-port laparoscopic surgery system to other surgical Instrument control systems, such as traditional thoracoscopy or open surgery.
Time frame: 30 days after surgery
The incidence rate of instrument-related or potentially instrument-related surgical complications meeting Clavien-Dindo grade 3 or above criteria from the time of incision
Time frame: Within 1 day after surgery
The amount of intraoperative bleeding from the start to the end of the surgery in the study subjects
Time frame: Within 1 day after surgery
Time frame: Within 30 day after surgery
The total number of days of hospitalization from the day of surgery to discharge for the study subjects.
If a subject is admitted in the afternoon or discharged in the morning, the day of admission or discharge is recorded as 0.5 days.
Time frame: 1, 24 and 72 hours after surgery
Assessment will be conducted using the Numerical Rating Scale (NRS)
Time frame: Within 4 hours after surgery
The surgeon satisfaction survey questionnaire consists of two parts: performance-related (12 questions) and surgeon comfort-related ratings (8 questions). The scoring criteria are as follows: Each question is scored on a scale of 1-5, with a maximum score of 5. The total score is out of 100
Time frame: Within 1 day after surgery
Incidence of adverse events (AE), serious adverse events (SAE), and overall surgical complication rate (evaluated using the Clavien-Dindo grading system)
Time frame: 30 days after discharge
Time frame: 30 days after surgery
Time frame: 30 days after surgery
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of Guangzhou Medical University
Other
Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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