Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical robot system.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study
Overview
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.
Interventions
- Procedure Surgical robot system
SHURUI Single-port surgical robot system
Primary outcome measures
- Intraoperative conversion rate [Time frame: Within 1 day after surgery]
- Surgical complications rate [Time frame: 30 days after surgery]
Secondary outcome measures (9)
- Intraoperating bleeding volume [Time frame: Within 1 day after surgery]
- Surgical time [Time frame: Within 1 day after surgery]
- Length of hospital admissions [Time frame: Within 30 day after surgery]
- Postoperative wound pain score [Time frame: 1, 24 and 72 hours after surgery]
- Surgeon satisfaction [Time frame: Within 4 hours after surgery]
- Adverse events [Time frame: Within 1 day after surgery]
- Rate of re-admission to hospital [Time frame: 30 days after discharge]
- Rate of reoperation [Time frame: 30 days after surgery]
- Postoperative mortality [Time frame: 30 days after 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT06286150 · EC-2023-087(QX)-03