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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Surgical robot system

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianxing He, M.D.; Phone Number: +86-20-83337792; Email: hejx@vip.163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Jianxing He, M.D.; Phone Number: +86-20-83337792; Email: hejx@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-port robot group	Procedure: Surgical robot system; SHURUI Single-port surgical robot system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality		30 days after surgery
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
Surgical time		Within 1 day after surgery
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
Postoperative wound pain score	Assessment will be conducted using the Numerical Rating Scale (NRS)	1, 24 and 72 hours after surgery
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
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
Rate of re-admission to hospital		30 days after discharge
Rate of reoperation		30 days after surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: safety; efficacy; thoracic surgery; surgical robot system
• Other Study ID Numbers: EC-2023-087(QX)-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No