Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intraoperative conversion rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Intraoperative conversion rate
时间窗: 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.
Surgical complications rate
时间窗: 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
次要结局
- Surgical time(Within 1 day after surgery)
- Postoperative wound pain score(1, 24 and 72 hours after surgery)
- Surgeon satisfaction(Within 4 hours after surgery)
- Rate of reoperation(30 days after surgery)
- Postoperative mortality(30 days after surgery)
- Intraoperating bleeding volume(Within 1 day after surgery)
- Length of hospital admissions(Within 30 day after surgery)
- Adverse events(Within 1 day after surgery)
- Rate of re-admission to hospital(30 days after discharge)
研究者
Jianxing He
Director
The First Affiliated Hospital of Guangzhou Medical University