None
Conditions
Interventions
Case group:None
Sponsors
Hebei Provincial Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, no gender restrictions; 2. Surgical approach: endoscopic surgery; 3. Surgical type: any of the following: general surgery or thoracic surgery; 4. Research instruments used intraoperatively: all marketed staplers and component models/specifications listed in Section 2.4.
Exclusion criteria
Exclusion criteria: 1. For use on inflamed, oedematous, ischaemic, necrotic tissue or tumour tissue; 2. Surgical or off-label use involving compression of tissue thicknesses below or exceeding the device's specified range; 3. For use on the liver or spleen; 4. Use on vascular tissue, the heart, the central circulatory system, or the central nervous system; 5. Use in combination with other similar products (stapler components) for resection, transection, or anastomosis at the surgical site; 6. Cases where surgical records are incomplete and key indicator information cannot be retrieved; 7. Pregnant women or women who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomosis success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anastomotic leakage rate;Post-operative bleeding/hemorrhage rate;Wound infection rate;Anastomotic stenosis/stricture rate;Postoperative pancreatic fistula rate;Bronchopleural fistula rate;Abscess rate;Adverse events;Device deficiencies;Serious adverse events; | — |
Countries
China
Contacts
Public ContactLizhong Shen
Hebei Provincial Traditional Chinese Medicine Hospital
Outcome results
None listed