Digestive system diseases, urogenital system diseases, respiratory system diseases
Conditions
Interventions
Experimental group:Thoracoabdominal Endoscopic Surgical System
Sponsors
Children's Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 0–18 years (excluding 18 years), regardless of gender; 2. Indications for pediatric thoracoabdominal surgery and physiological suitability for laparoscopic surgery; 3. When the subject is a person without civil capacity or with limited civil capacity, written informed consent must be obtained from their legal guardian in accordance with applicable law; when the subject is capable of expressing their own opinion, their personal consent is also required.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of prior laparoscopic or open surgery at the intended surgical site, deemed unsuitable for laparoscopic surgery by the investigator; 2. Patients with thoracic/abdominal/pelvic infection, peritonitis, diaphragmatic hernia, or severe systemic infection, deemed unsuitable for laparoscopic surgery by the investigator; 3. Patients with severe bleeding tendency or coagulation dysfunction (APTT = 1.5 times the upper limit of normal), those on long-term anticoagulant or antiplatelet therapy, or those who discontinued anticoagulant or antiplatelet agents less than one week prior to surgery (prophylactic use of low-molecular-weight heparin preoperatively excluded); 4. Patients with severe cardiovascular or circulatory system disease who cannot tolerate surgery; 5. Patients with epilepsy or cognitive impairment; 6. Patients suspected of or diagnosed with drug addiction; 7. Pregnant women; 8. Patients who participated in another interventional device clinical trial within one month prior to this trial or in a drug clinical trial within three months prior to this trial; 9. Patients found intraoperatively unsuitable for laparoscopic surgery—for example, when the surgeon identifies severe adhesions, anatomical variations, or inadequate exposure around the surgical site during intraoperative exploration, and determines that laparoscopic surgery is inappropriate; 10. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Unconverted Surgery;Incidence of device-related or possibly device-related complications meeting Clavien-Dindo grade 3 or higher criteria from the first incision through postoperative day 30; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery Time;Estimated intraoperative blood loss (mL);Pediatric Pain Score;Blood transfusion rate;Length of Hospital Stay;Instrument Performance Evaluation;Surgeon’s Intraoperative Physiological Load Assessment; | — |
Countries
China
Contacts
Public ContactZhigang Gao
Children's Hospital, School of Medicine, Zhejiang University
Outcome results
None listed