parastoma hernia
Conditions
Interventions
Experimental group:Preventive use of patch in colostomy
Control Group:General colostomy
Sponsors
Shanghai Pine&Power Biotech Co.,Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, no gender limit; 2. Requires elective permanent sigmoid colostomy surgery; 3. First time permanent sigmoid colostomy surgery; 4. In line with the American Society of Anesthesiologist score with I-III; 5. The patients or their guardians can understand the purpose of trial, be willing to cooperate surgery and follow-ups and voluntarily participate in the trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients whose life expectancy is less than 12 months; 2. Patients undergoing permanent colostomy in the emergency department; 3. Patients who have had other operations at the colostomy; 4. Patients with acute infections or poorly controlled lesions with skin diseases around the surgical incision; 5. Patients with a clear history of allergies to test materials (PLCL, fibrinogen); 6. Concomitant with various malignant tumors and chronic wasting diseases that cause cachexia and cannot tolerate surgery; 7. Patients with vital organ failure or other serious diseases; 8. Those who have participated in other clinical trials within the past 3 months; 9. The investigator judges that the patient has other factors that are not suitable for this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of preventing parastoma hernia 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery success rate;Effective rate of preventing parastoma hernia at 6 months after operation;Quality of life score (SF-12 score); | — |
Countries
China
Contacts
Public ContactCai Sanjun
Outcome results
None listed