colorectal cancer
Conditions
Interventions
Experimental group:Prophylactic colostomy with biological patch
Control Group:Conventional colostomy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years male or female; 2. Whether benign or malignant disease that requires elective permanent colostomy in patients with oral surgery; 3. First line of permanent colostomy in patients with oral surgery; 4. In line with the American Society of Anesthesiologist score of patients with I-III; 5. Subjects or their guardians can understand the purpose of testing, surgery and follow-up willing to cooperate voluntarily participate in the trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Life expectancy in patients less than 12 months; 2. Emergency line permanent colostomy in patients with oral surgery; 3. Ileostomy patient; 4. Colostomy patients undergoing secondary correction; 5. There are other patients had surgery at the colostomy; 6. Acute infections or lesions in poor infection control, skin diseases around the surgical incision; 7. There are patients with a clear history of allergy test material (PLCL, fibrinogen); 8. Associated with various malignancies, chronic wasting disease causing cachexia, can not tolerate surgery; 9. Important organ failure or other serious diseases (including the 12 months before enrollment myocardial infarction, severe cardiomyopathy and have refractory heart failure; 12 months prior to enrollment serious neurological disease; consolidation of central nervous system diseases , Such as a history of epilepsy, cerebral infarction or cerebral hemorrhage; patients with severe shock that is difficult to correct with drugs; patients with active tuberculosis; patients with bleeding disorders or bleeding tendency); 10. Severe liver failure disease (ALT and AST were greater than 3 ULN); 11. Severe renal failure (eGFR =11.1mmol/L); 13. Is participating in other clinical trials of drugs or devices without reaching the primary endpoint of time-limited subjects; 14. By clinician determines other factors not suitable for patients with this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of preventing parastoma hernia 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgery success rate;Success rate of preventing parastoma hernia at 3 and 6 months after operation;Changes in the quality of life score (SF-12 score); | — |
Countries
China
Contacts
Public ContactShi Debing
Fudan University Shanghai Cancer Center
Outcome results
None listed