Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery: An Exploratory Study of a Novel Robotic System
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Conversion rate
研究概览
简要总结
This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.
详细描述
Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general 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
- •18 years < age ≤75 years
- •Suitable for minimally invasive surgery
- •18.5≤BMI≤28 kg/m2
- •ASA score is Ⅰ-Ⅲ
- •Informed consent
- •Colon and rectal resection: colon and rectal polyps, inflammatory bowel disease, intestinal diverticula, colorectal cancer diagnosed cT3N0M0 with a maximum diameter of ≤4 cm located above the peritoneal reflection.
- •Partial gastrectomy: gastric stromal tumor, gastric giant ulcer.
- •Appendectomy: chronic appendicitis.
- •Cholecystectomy: chronic cholecystitis combined with gallbladder stones, gallbladder polyps (> 1 cm).
排除标准
- •With other malignancies or a previous history of other malignancies
- •Undergone other major surgical treatment within 3 months prior to enrolment or planned during the trial
- •With active tuberculosis
- •With severe systemic disease
- •With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
- •With severe allergies and suspected or established alcohol, drug or substance addiction
- •Patients who are immunodeficiency virus (HIV) antibody positive; hepatitis B surface antigen (HbsAg) positive and have a hepatitis B virus DNA (HBV-DNA) copy number above the lower limit of detection or normal range; hepatitis C virus (HCV) antibody positive; syphilis spirochete antibody positive and at high risk of transmission as judged by the investigator.
- •Emergency surgery
- •Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- •Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
结局指标
主要结局
Conversion rate
时间窗: intraoperative
The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars
次要结局
- Operative time(intraoperative)
- Intraoperative blood loss(intraoperative)
- Length of stay(1-14 days after surgery)
- Incision healing(1-14 days after surgery)
- Early morbidity rate(30 days after surgery)