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NCT Number: NCT06286150

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Jianxing He, M.D.

CONTACT

[email protected]

+86-20-83337792

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical robot system

Procedure

SHURUI Single-port surgical robot system

Primary outcomes

  1. Intraoperative conversion rate

    Time frame: 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.

  2. Surgical complications rate

    Time frame: 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

Secondary outcomes

  1. Intraoperating bleeding volume

    Time frame: Within 1 day after surgery

    The amount of intraoperative bleeding from the start to the end of the surgery in the study subjects

  2. Surgical time

    Time frame: Within 1 day after surgery

  3. Length of hospital admissions

    Time frame: Within 30 day after surgery

    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.

  4. Postoperative wound pain score

    Time frame: 1, 24 and 72 hours after surgery

    Assessment will be conducted using the Numerical Rating Scale (NRS)

  5. Surgeon satisfaction

    Time frame: Within 4 hours after surgery

    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

  6. Adverse events

    Time frame: Within 1 day after surgery

    Incidence of adverse events (AE), serious adverse events (SAE), and overall surgical complication rate (evaluated using the Clavien-Dindo grading system)

  7. Rate of re-admission to hospital

    Time frame: 30 days after discharge

  8. Rate of reoperation

    Time frame: 30 days after surgery

  9. Postoperative mortality

    Time frame: 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Jianxing He, M.D.

CONTACT

[email protected]

+86-20-83337792

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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