Colorectal Cancer, Esophageal Cancer, Hepatectomy, Radical Hysterectomy
Conditions
Keywords
distal gastric cancer, radical surgery, colorectal cancer, hepatectomy, radical hysterectomy
Brief summary
Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery
Detailed description
This trial adopts a prospective, multicenter, single-arm objective value design.For subjects scheduled to undergo thoracoabdominal endoscopic surgery system-assisted laparoscopic surgeries in the departments of urology, general surgery, gynecology and thoracic surgery, the thoracoabdominal endoscopic surgery system developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. will be used to perform remote laparoscopic surgeries in the above four departments, and the efficacy and safety of the investigational medical device in the treatment of remote laparoscopic surgeries in these four departments will be evaluated.
Interventions
DEVICERobot-assisted surgery
Surgery with the Cornerstone Surgical Robot.
Sponsors
Cornerstone Robotics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 80 years; * Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.). * Subjects voluntarily participate in the clinical trial, and subjects or their guardians give informed consent and sign the informed consent form. * Willing to cooperate with and complete trial follow-ups and relevant examinations.
Exclusion criteria
* Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.); * With other malignancies or a previous history of other malignancies. * Preoperative imaging suggests that the tumour has distant metastases. * The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment. * Severe bleeding tendencies or coagulopathic disorders. * 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. * Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids). * Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical non-referral rate | during the surgery | Surgical untransferred is defined as not converted from an experimental medical device assisted method to another surgical device control system assisted, laparoscopic surgery or open surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The surgeon's operating time | during the surgery | Operative time（minutes） |
| Intraoperative blood loss | during the surgery | Estimated blood loss（milliliters，ml） |
| Length of stay | The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively. | The postoperative day when patients complied with the predefined discharge criteria |
Outcome results
None listed