The First Affiliated Hospital of Guangzhou Medical University
Phase
Not applicable
Started
2023-09-15
Last updated
2024-02-29
Condition(s) studied
Lung Cancer
Investigational drug(s) / intervention(s)
Surgical robot system
Surgical robot system: SHURUI Single-port surgical robot system
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 18 and 75 years, regardless of gender.
* Patients who require endoscopic surgical treatment and have indications for lung segment/lobe resection; for pre-trial subjects, there is no restriction on the type of procedure, and inclusion is based on the investigator's judgment of having indications for thoracic surgery.
* Preoperative ASA classification of I-III.
* Voluntary participation in the clinical trial and willingness to provide informed.
consent, either by the subject or their guardian.
* Willingness to cooperate and complete trial follow-up and related examinations.
Exclusion Criteria:
* Patients with a history of thoracic surgery or previous history of other malignant tumors deemed unsuitable for inclusion by the investigator.
* Patients with severe comorbidities (cardiac, pulmonary, hepatic, cerebral, renal diseases) or physical weakness who cannot tolerate general anesthesia or surgery.
* Patients with severe bleeding tendencies or coagulation disorders.
* Patients in the active phase of infectious diseases or with other severe non-communicable infections.
* Patients positive for Human Immunodeficiency Virus (HIV) antibodies or syphilis seropositive patients.
* Patients with a suspected or confirmed alcohol, drug, or substance addiction.
* Patients with a history of epilepsy, mental illness, or cognitive impairment.
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
* Participation in other interventional clinical trials within 3 months prior to signing the informed consent form.
* Other situations in which the investigator deems inappropriate for participation in this clinical trial.
Primary outcome measure(s)
Intraoperative conversion rate — 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.
Surgical complications rate — 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
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More The First Affiliated Hospital of Guangzhou Medical University trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.