Clinical trial NCT06286150: Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery
Official title: Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: surgical robot system
efficacy
safety
thoracic surgery
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Intraoperative conversion rate
timeFrame: Within 1 day after surgery
measure: Surgical complications rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Intraoperating bleeding volume
timeFrame: Within 1 day after surgery
measure: Surgical time
timeFrame: Within 1 day after surgery
measure: Length of hospital admissions
timeFrame: Within 30 day after surgery
measure: Postoperative wound pain score
timeFrame: 1, 24 and 72 hours after surgery
measure: Surgeon satisfaction
timeFrame: Within 4 hours after surgery
measure: Adverse events
timeFrame: Within 1 day after surgery
measure: Rate of re-admission to hospital
timeFrame: 30 days after discharge
measure: Rate of reoperation
timeFrame: 30 days after surgery
measure: Postoperative mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: