Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery

Lung Cancer Clinical Trial

Official title:

Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286150
• Other study ID #: EC-2023-087(QX)-03
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: July 15, 2027

Study information

• Verified date: February 2024
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jianxing He, M.D.
• Phone: +86-20-83337792
• Email: hejx[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 15, 2027
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Surgical robot system
SHURUI Single-port surgical robot system

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative conversion rate	The conversion from a single-port laparoscopic surgery system to other surgical Instrument control systems, such as traditional thoracoscopy or open surgery.	Within 1 day after surgery
Primary	Surgical complications rate	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	30 days after surgery
Secondary	Intraoperating bleeding volume	The amount of intraoperative bleeding from the start to the end of the surgery in the study subjects	Within 1 day after surgery
Secondary	Surgical time		Within 1 day after surgery
Secondary	Length of hospital admissions	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.	Within 30 day after surgery
Secondary	Postoperative wound pain score	Assessment will be conducted using the Numerical Rating Scale (NRS)	1, 24 and 72 hours after surgery
Secondary	Surgeon satisfaction	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	Within 4 hours after surgery
Secondary	Adverse events	Incidence of adverse events (AE), serious adverse events (SAE), and overall surgical complication rate (evaluated using the Clavien-Dindo grading system)	Within 1 day after surgery
Secondary	Rate of re-admission to hospital		30 days after discharge
Secondary	Rate of reoperation		30 days after surgery
Secondary	Postoperative mortality		30 days after surgery