Gastric Cancer
Conditions
Interventions
Experimental group:perform anastomosis-suture with reinforcement-repair patch
Control group:perform anastomosis-suture without reinforcement-repair patch
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participating in this study and signed informed consent; 2. Age ranged between 18 and 75 years; 3. Pathological confirmation with gastric adenoicarcinoma; 4. Satisfied the indications for partial gastrectomy and were scheduled for radical distal gastrectomy.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of upper abdominal surgery (except for cholecystectomy); 2. Having comorbid blood and autoimmune system diseases; 3. Patients who had an allergy to collagen or porcine-derived biomaterials; 4. Patients who had intraperitoneal infection symptoms such as signs of peritoneal irritation; 5. Abdominal pain and fever, cardiac dysfunction (EF (ejection fraction) = 3); 6. Pyloric obstruction or gastric retention; 7. Abnormal liver or kidney function (ALT (alanine aminotransferase) or AST (aspartate aminotransferase) more than 2.5 times the upper limit of normal value, or Cr (creatinine level) more than 1,5 times the upper limit of normal value); 8. Hemoglobin levels were less than 70 g/L at the time of screening; 9. Platelets were less than 8 x 10^9 /L at the time of screening; 10. Taking anticoagulants, coagulation function index values including APTT (activated partial thromboplastin time), PT (plasma prothrombin time), TT (thrombin time) and INR (international normalized ratio) out of 80% range of reference value; 11. Patients who had undergone preoperative radiotherapy or chemotherapy; 12. Patients who refused to participate in the study due to religious affiliation; 13. The expected survival less than one year; 14. Menstruating, pregnant and lactating females; 15. The results of serological virological test showing communicable diseases including hepatitis B, C or HIV infection and et al; 16. Patients who had fertility intention; 17. Patients who had participated in any other clinical trials within 3 months; 18. Some certain diseases or conditions that placed the subjects at a significant risk, interfered with the research results, or influenced participation of gastric cancer patients in our study were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bleeding spots per centimeter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of pulsing hemorrhagic spots per centimeter;Amount of bleeding between anastomosis and hemostasis completion;Duration of hemostasia;duration of total operation;performance parameters of staplers; | — |
Countries
China
Contacts
Public ContactHu Jiankun
West China Hospital of Sichuan University
Outcome results
None listed