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

NCT06286150 | Recruiting

• 1 other identifier: EC-2023-087(QX)-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

surgical robot system; efficacy; safety; thoracic surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Intraoperating bleeding volume

  Within 1 day after surgery

• Surgical time

  Within 1 day after surgery

• Length of hospital admissions

  Within 30 day after surgery

• Postoperative wound pain score

  1, 24 and 72 hours after surgery

• Surgeon satisfaction

  Within 4 hours after surgery

Study Arms (1)

single-port robot group

EXPERIMENTAL

Procedure: Surgical robot system

Interventions

Surgical robot system PROCEDURE

SHURUI Single-port surgical robot system

single-port robot group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years, regardless of gender.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jianxing He, M.D.

CONTACT

+86-20-83337792; hejx@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 29, 2024
• Study Start: September 15, 2023
• Primary Completion: July 15, 2025
• Study Completion (Estimated): July 15, 2027
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

CN (1)