None
Conditions
Interventions
Experimental group:The Thoraco-abdominal Endoscopic Surgery System and the Single-use Ultrasonic Soft Tissue Surgical Scalpel
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 80 years old (inclusive), gender not restricted; 2. BMI: 18.5 - 30 kg/m^2; 3. Plan to undergo laparoscopic surgery assisted by the surgical thoracic and abdominal endoscopic system, and based on preoperative imaging examinations and/or the investigator's judgment, the use of an ultrasonic knife head is required for soft tissue cutting and hemostasis, and the closure of blood vessels with a diameter <= 5mm. 4. Voluntary participation in this clinical study. Willing to cooperate and complete the study follow-up and related examinations, and sign the informed consent form for the subject.
Exclusion criteria
Exclusion criteria: 1. Those who require emergency surgery due to changes in their condition; 2. Those with severe coagulation dysfunction and obvious bleeding tendency; 3. Active infections (either throughout the body or locally); 4. Those with severe cardiovascular or cerebrovascular diseases, organ failure, or other systemic diseases, and whose condition has been assessed by the researchers as being intolerable for anesthesia or laparoscopic surgery; 5. Those with a history of major abdominal or pelvic surgeries, or who have severe abdominal or pelvic inflammation, adhesions, or large amounts of fluid accumulation, etc., which are contraindications for laparoscopic surgery; 6. Those with extensive metastasis of abdominal or pelvic tumors or extensive infiltration of surrounding tissues; 7. Pregnant or lactating women; 8. Those who are currently participating in other clinical studies of drugs or medical devices; 9. Those who, in the opinion of the researchers, are not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical non-reoperation rate;Incidence of Device-Related or Possibly Device-Related Complications Meeting Clavien-Dindo Grade 3 or Higher from First Incision to 30 Days Postoperative; | — |
Secondary
| Measure | Time frame |
|---|---|
| Installation Time;Incidence of Serious Adverse Events;Adverse Event Rate;Postoperative Flatulence Time;Overall Complication Rate from First Incision to 30 Days Postoperative (Clavien-Dindo Grade 1 or Higher);30-Day Readmission RatReoperation RateMortality Rate;Surgeon Satisfaction Rating;Transfusion Rate;Portal Triad Clamping Time (applicable to liver surgery only);Postoperative Drainage Output;Operative Time;Postoperative Hospital Stay;Patient Pain Score;Estimated Intraoperative Blood Loss (mL); | — |
Countries
China
Contacts
Public ContactQin Lei
The First Affiliated Hospital of Soochow University
Outcome results
None listed